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Meta-Analysis
. 2019 Mar 13;3(3):CD012473.
doi: 10.1002/14651858.CD012473.pub2.

Probiotics to prevent infantile colic

Teck Guan Ong  1 , Morris Gordon, Shel Sc Banks, Megan R Thomas, Anthony K Akobeng
Affiliations
Meta-Analysis

Probiotics to prevent infantile colic

Teck Guan Ong et al. Cochrane Database Syst Rev. .

Abstract

Background: Infantile colic is typically defined as full-force crying for at least three hours per day, on at least three days per week, for at least three weeks. Infantile colic affects a large number of infants and their families worldwide. Its symptoms are broad and general, and while not indicative of disease, may represent a serious underlying condition in a small percentage of infants who may need a medical assessment. Probiotics are live microorganisms that alter the microflora of the host and provide beneficial health effects. The most common probiotics used are of Lactobacillus, Bifidobacterium and Streptococcus. There is growing evidence to suggest that intestinal flora in colicky infants differ from those in healthy infants, and it is suggested that probiotics can redress this balance and provide a healthier intestinal microbiota landscape. The low cost and easy availability of probiotics makes them a potential prophylactic solution to reduce the incidence and prevalence of infantile colic.

Objectives: To evaluate the efficacy and safety of prophylactic probiotics in preventing or reducing severity of infantile colic.

Search methods: In January 2018 we searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, 10 other databases and two trials registers. In addition, we handsearched the abstracts of relevant meetings, searched reference lists, ran citation searches of included studies, and contacted authors and experts in the field, including the manufacturers of probiotics, to identify unpublished trials.

Selection criteria: Randomised control trials (RCTs) of newborn infants less than one month of age without the diagnosis of infantile colic at recruitment. We included any probiotic, alone or in combination with a prebiotic (also known as synbiotics), versus no intervention, another intervention(s) or placebo, where the focus of the study was the effect of the intervention on infantile colic.

Data collection and analysis: We used standard methodological procedures of Cochrane.

Main results: Our search yielded 3284 records, and of these, we selected 21 reports for full-text review. Six studies with 1886 participants met our inclusion criteria, comparing probiotics with placebo. Two studies examined Lactobacillus reuteri DSM, two examined multi-strain probiotics, one examined Lactobacillus rhamnosus, and one examined Lactobacillus paracasei and Bifidobacterium animalis. Two studies began probiotics during pregnancy and continued administering them to the baby after birth.We considered the risk of bias for randomisation as low for all six trials; for allocation concealment as low in two studies and unclear in four others. All studies were blinded, and at low risk of attrition and reporting bias.A random-effects meta-analysis of three studies (1148 participants) found no difference between the groups in relation to occurrence of new cases of colic: risk ratio (RR) 0.46, 95% confidence interval (CI) 0.18 to 1.19; low-certainty evidence; I2 = 72%.A random-effects meta-analysis of all six studies (1851 participants) found no difference between the groups in relation to serious adverse effects (RR 1.02, 95% CI 0.14 to 7.21; low-certainty evidence; I2 not calculable (only four serious events for one comparison, two in each group: meconium plug obstruction, patent ductus arteriosus and neonatal hepatitis).A random-effects meta-analysis of three studies (707 participants) found a mean difference (MD) of -32.57 minutes per day (95% CI -55.60 to -9.54; low-certainty evidence; I2 = 93%) in crying time at study end in favour of probiotics.A subgroup analysis of the most studied agent, Lactobacillus reuteri, showed a reduction of 44.26 minutes in daily crying with a random-effects model (95% CI -66.6 to -21.9; I2 = 92%), in favour of probiotics.

Authors' conclusions: There is no clear evidence that probiotics are more effective than placebo at preventing infantile colic; however, daily crying time appeared to reduce with probiotic use compared to placebo. There were no clear differences in adverse effects.We are limited in our ability to draw conclusions by the certainty of the evidence, which we assessed as being low across all three outcomes, meaning that we are not confident that these results would not change with the addition of further research.

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Conflict of interest statement

TGO: none.

MG is employed by Blackpool Victoria Hospital (NHS) and declares that he received some financial support from the Trust to employ a Research Assistant; however, they had no involvement in the planning or execution of this review. MG has received travel grants from 2016 to 2019 from Ferring and BioGaia to attend scientific meetings and these companies produce treatments for colic that may be tested in this study. MG declares that these companies had no involvement in the planning, design or conceptual planning of this study. MG has received travel grants from Tillotts Pharma and Synergy Pharmaceuticals to attend meetings to present the results of previous works. They have had no input or involvement in any aspect of the review process during this or previous systematic reviews carried out by MG, such as Bowel preparation for paediatric colonoscopy (Gordon 2012) and Probiotics for maintenance of remission in ulcerative colitis (Naidoo 2011).

SSCB is being paid as a Research Assistant for this review from Blackpool Teaching Hospitals NHS Foundation Trust*. SSCB is Chair of the Local Infant Feeding Information Board (LIFIB), which produces evidence‐based information on infant feeding topics for health professionals. SSCB is a self‐employed Infant Feeding Information Specialist and provides expertise in infant feeding, writing briefing papers and newsletters, etc., and delivering workshops across the northwest of England. This is for the LIFIB and the Sudden Unexpected Death of a Child Prevention Team in Lancashire. Money from Lancashire County Council, via The Breastfeeding Network, funds the latter, and work related to this is paid for by the hour. SSCB is self‐employed as an International Board Certified Lactation Consultant in private practice. SSCB is a Committee Member of the main Lactation Consultants of Great Britain (LCGB) Committee and Chair of the Communications Team. She is also Chair of the committee for the Breastfeeding Festival, which puts on one × two‐day event each year to celebrate breastfeeding and provide interesting and educational speaker sessions on infant feeding. All of these positions are unfunded and voluntary but travel expenses are paid. SSCB declares that she was a Lay Member on the National Institute for Health and Care Excellence (NICE) Guideline Committee on Faltering Growth in Infants and Children from 2015 to 2017 for which she was paid an honorarium by NICE. She also declares that she is a trustee of the UK Association of Milk Banking; an unfunded position with travel expenses up to twice a year, and sometimes accommodation at conferences to run stalls etc. are paid. SSCB declares that neither she personally nor any of the entities that she represents take funding of any kind from any commercial interests in infant feeding or early years, and that she works completely within the professional code of ethics as an International Board Certified Lactation Consultant.

MRT has been part of an advisory board for Roche related to a study for people with Down's syndrome about improving cognition. MRT was reimbursed for her travel costs, and her Trust received fees for her time. MRT confirms that she has not received any fees from any other commercial sources from 2015 to 2018.

AA: none.

*Disclaimer: MRT, MG, TGO are members of staff of the Blackpool Victoria Hospital. The authors alone are responsible for the views expressed herein; they do not necessarily represent the decisions, policy or views of the NHS or Department of Health.

Figures

1
1
Study flow diagram. RCT: randomised controlled trial.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Forest plot of comparison: 1 Probiotic preparation versus placebo, outcome: 1.1 Occurrence of new cases of colic: random‐effects model.
4
4
Forest plot of comparison: 1 Probiotic preparation versus placebo, outcome: 1.4 Crying time: random‐effects model (minutes/day).
5
5
Forest plot of comparison: 1 Probiotic preparation versus placebo, outcome: 1.7 Mean crying time at study end: random‐effects model.
6
6
Forest plot of comparison: 1 Probiotic preparation versus placebo, outcome: 1.8 Mean crying time at study end: fixed‐effect model.
1.1
1.1. Analysis
Comparison 1 Probiotic preparation versus placebo, Outcome 1 Occurrence of new cases of colic: random‐effects model.
1.2
1.2. Analysis
Comparison 1 Probiotic preparation versus placebo, Outcome 2 Occurrence of new cases of colic: sensitivity analysis with fixed‐effect model.
1.3
1.3. Analysis
Comparison 1 Probiotic preparation versus placebo, Outcome 3 Serious adverse effects.
1.4
1.4. Analysis
Comparison 1 Probiotic preparation versus placebo, Outcome 4 Duration of crying random‐effects model.
1.5
1.5. Analysis
Comparison 1 Probiotic preparation versus placebo, Outcome 5 Duration of crying: sensitivity analysis with fixed‐effect model.
1.6
1.6. Analysis
Comparison 1 Probiotic preparation versus placebo, Outcome 6 Duration of crying: subgroup analysis with term babies only.
1.7
1.7. Analysis
Comparison 1 Probiotic preparation versus placebo, Outcome 7 Occurrence of colic: subgroup analysis with pregnant women.
1.8
1.8. Analysis
Comparison 1 Probiotic preparation versus placebo, Outcome 8 Mean duration of crying at study end: random‐effects model, subgroup L Reuteri.
1.9
1.9. Analysis
Comparison 1 Probiotic preparation versus placebo, Outcome 9 Mean duration of crying at study end: sensitivity analysis with fixed‐effect model.
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References

References to studies included in this review

Baldassarre 2014 {published data only}
    1. Baldassarre ME, Mauro A, Mastromarino P, Fanelli M, Martinelli D, Urbano F, et al. Administration of a multi‐strain probiotic product to women in the perinatal period differentially affects the breast milk cytokine profile and may have beneficial effects on neonatal gastrointestinal functional symptoms. A randomized clinical trial. Nutrients 2016;8(11):E677. [DOI: 10.3390/nu8110677; PMC5133065; PUBMED: 27801789] - DOI - PMC - PubMed
    1. Baldassarre ME, Mastromarino P, Miccheli A, Fanelli M, Dileone A, Drimaco P, et al. PS‐054 Vsl#3 supplementation to mothers during pregnancy and breast feeding improves colics and regurgitation in newborns, perhaps by TGF‐b modulation. Archives of Disease in Childhood 2014;99(Suppl 2):A131‐2. [DOI: 10.1136/archdischild-2014-307384.352] - DOI
Indrio 2008 {published data only}
    1. Indrio F, Riezzo G, Raimondo F, Bisceglia M, Cavallo L, Francavilla R. The effects of probiotics on feeding tolerance, bowel habits, and gastrointestinal motility in preterm newborns. Journal of Pediatrics 2008;152(6):801‐6. [DOI: 10.1016/j.jpeds.2007.11.005; PUBMED: 18492520] - DOI - PubMed
Indrio 2014 {published data only}
    1. Indrio F, Mauro A, Riezzo G, Civardi E, Intini C, Corvaglia L, et al. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. JAMA Pediatrics 2014;168(3):228‐33. [DOI: 10.1001/jamapediatrics.2013.4367; NCT01235884; PUBMED: 24424513] - DOI - PubMed
    1. Indrio F, Riezzo G, Mauro A, Civardi E, Garofoli F, Intini AC, et al. Probiotic supplementation for prevention of functional gastrointestinal disorders in the first month of life: an Italian multicentric study. Digestive and Liver Disease 2012;44(Suppl 4):S286. [DOI: 10.1016/S1590-8658(12)60730-0; P066] - DOI
Kukkonen 2008 {published data only}
    1. Kukkonen K, Savilahti E, Haahtela T, Juntunen‐Backman K, Korpela R, Poussa T, et al. Long‐term safety and impact on infection rates of postnatal probiotic and prebiotic (synbiotic) treatment: randomized, double‐blind, placebo‐controlled trial. Pediatrics 2008;122(1):8‐12. [DOI: 10.1542/peds.2007-1192; NCT00298337; PUBMED: 18595980] - DOI - PubMed
    1. Kukkonen K, Savilahti E, Haahtela T, Juntunen‐Backman K, Korpela R, Tuija Poussa T, et al. Probiotics and prebiotic galacto oligosaccharides in the prevention of allergic diseases: a randomized, double‐blind, placebo‐controlled trial. Journal of Allergy and Clinical Immunology 2007;119(1):192‐8. [DOI: 10.1016/j.jaci.2006.09.009] - DOI - PubMed
Pärtty 2013a {published data only}
    1. Pärtty A, Luoto R, Kalliomäki M, Salminen S, Isolauri E. Effects of early prebiotic and probiotic supplementation on development of gut microbiota and fussing and crying in preterm infants: a randomized, double‐blind, placebo‐controlled trial. Journal of Pediatrics 2013;163(5):1272‐7. [DOI: 10.1016/j.jpeds.2013.05.035; PUBMED: 23915796] - DOI - PubMed
Vlieger 2009 {published data only}
    1. Vlieger A, Robroch A, Buuren S, Kiers J, Rijkers G, Benninga M, et al. Tolerance and safety of Lactobacillus paracasei ssp. paracasei in combination with Bifidobacterium animalis ssp. lactis in a prebiotic‐containing infant formula: a randomised controlled trial. British Journal of Nutrition 2009;102(6):869‐75. [DOI: 10.1017/S0007114509289069] - DOI - PubMed

References to studies excluded from this review

Cekola 2015 {published data only}
    1. Cekola PL, Czerkies LA, Storm HM, Wang MH, Roberts J, Saavedra JM. Growth and tolerance of term infants fed formula with probiotic Lactobacillus reuteri. Clinical Pediatrics 2015;54(12):1175‐84. - PubMed
Di Mauro 2013 {published data only}
    1. Mauro A, Riezzo G, Civardi E, Intini C, Corvaglia L, Ballardini E, et al. Act and not react: prophylactic use of probiotic in colic, regurgitation and functional constipation, clinical and socio‐economic impact. Digestive and Liver Disease 2013;45(Suppl 4):e302. [DOI: 10.1016/j.dld.2013.08.222; P050] - DOI
Garofoli 2014 {published data only}
    1. Garofoli F, Civardi E, Indrio F, Mazzucchelli I, Angelini M, Tinelli C, et al. The early administration of Lactobacillus reuteri DSM 17938 controls regurgitation episodes in full‐term breastfed infants. International Journal of Food Sciences and Nutrition 2014;65(5):646‐8. [DOI: 10.3109/09637486.2014.898251; PUBMED: 24635827] - DOI - PubMed
Hoy‐Schulz 2016 {published data only}
    1. Hoy‐Schulz YE, Jannat K, Roberts T, Zaidi SH, Unicomb L, Luby S, et al. Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial. BMC Complementary and Alternative Medicine 2016;16:44. [DOI: 10.1186/s12906-016-1016-1; NCT01899378; PMC4736167; PUBMED: 26832746] - DOI - PMC - PubMed
Mommaerts 2011 {published data only}
    1. Mommaerts JL, Devroey D. It's too soon to recommend probiotics for colic. Journal of Family Practice 2011;60(5):251‐2. [PUBMED: 21692362] - PubMed
Olivares 2011 {published data only}
    1. Olivares M, Gil M, López M, Rodríguez M, Romero J, Roncero I, et al. Safety trial of an infant formula enriched with the human milk probiotic strain L.Fermentum Cect 5716. Annals of Nutrition and Metabolism 2011;58(Suppl 3):80‐1. [DOI: 10.1159/000334393; S27/452] - DOI
Pärtty 2013b {published data only}
    1. Pärtty A, Kalliomaki M, Salminen S, Isolauri E. Infant distress and development of functional gastrointestinal disorders in childhood: is there a connection?. JAMA Pediatrics 2013;167(10):977‐8. [DOI: 10.1001/jamapediatrics.2013.99; PUBMED: 23959380] - DOI - PubMed
Savino 2015 {published data only}
    1. Savino F, Ceratto S, Poggi E, Cartosio ME, Montezemolo C, Giannattasio A. Preventive effects of oral probiotic on infantile colic: a prospective, randomised, blinded, controlled trial using Lactobacillus reuteri DSM 17938. Beneficial Microbes 2015;6(3):245‐51. [DOI: 10.3920/BM2014.0090; PUBMED: 25488262] - DOI - PubMed
Simone 2014 {published data only}
    1. Simone M, Gozzoli C, Quartieri A, Mazzola G, Gioia D, Amaretti A, et al. The probiotic Bifidobacterium breve B632 inhibited the growth of Enterobacteriaceae within colicky infant microbiota cultures. BioMed Research International 2014;2014:e1‐7. [DOI: 10.1155/2014/301053; Article ID 301053] - DOI - PMC - PubMed
Szajewska 2013 {published data only}
    1. Szajewska H, Gyrczuk E, Horvath A. Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double‐blind, placebo‐controlled trial. Journal of Pediatrics 2013;162(2):257‐62. [DOI: 10.1016/j.jpeds.2012.08.004; NCT01046617; PUBMED: 22981952] - DOI - PubMed
Wade 2001 {published data only}
    1. Wade S, Kilgour T. Extracts from "Clinical Evidence": infantile colic. Clinical Evidence 2001;323:437‐40. [DOI: 10.1136/bmj.323.7310.437] - DOI - PMC - PubMed
Weizman 2006 {published data only}
    1. Weizman Z, Alsheikh A. Safety and tolerance of a probiotic formula in early infancy comparing two probiotic agents: a pilot study. Journal of the American College of Nutrition 2006;25(5):415‐9. [PUBMED: 17031011] - PubMed

Additional references

Ali 2012
    1. Ali AM. Helicobacter pylori and infantile colic. Archives of Pediatrics & Adolescent Medicine 2012;166(7):648‐50. [DOI: 10.1001/archpediatrics.2011.1241; PUBMED: 22751879] - DOI - PubMed
Arslanoglu 2012
    1. Arslanoglu S, Moro GE, Boehm G, Wienz F, Stahl B, Bertino E. Early neutral prebiotic oligosaccharide supplementation reduces the incidence of some allergic manifestations in the first 5 years of life. Journal of Biological Regulators and Homeostatic Agents 2012;26(3 Suppl):49‐59. [PUBMED: 23158515] - PubMed
Axelsson 1986
    1. Axelsson I, Jakobsson I, Lindberg T, Benediktsson B. Bovine beta‐lactoglobulin in the human milk. A longitudinal study during the whole lactation period. Acta Paediatrica Scandinavica 1986;75(5):702‐7. [PUBMED: 3564937] - PubMed
Baldassarre 2010
    1. Baldassarre ME, Laforgia N, Fanelli M, Laneve A, Grosso R, Lifschitz C. Lactobacillus GG improves recovery in infants with blood in the stools and presumptive allergic colitis compared with extensively hydrolyzed formula alone. Journal of Pediatrics 2010;156(3):397‐401. [DOI: 10.1016/j.jpeds.2009.09.012; PUBMED: 19880141] - DOI - PubMed
Baldassarre 2016
    1. Baldassarre ME, Mauro A, Mastromarino P, Fanelli M, Martinelli D, Urbano F, et al. Administration of a multi‐strain probiotic product to women in the perinatal period differentially affects the breast milk cytokine profile and may have beneficial effects on neonatal gastrointestinal functional symptoms. A randomized clinical trial. Nutrients 2016;8(11):E677. [DOI: 10.3390/nu8110677; PMC5133065; PUBMED: 27801789] - DOI - PMC - PubMed
Braeggar 2011
    1. Braegger C, Chmielewska A, Decsi T, Kolacek S, Mihatsch W, Moreno L, et al. Supplementation of infant formula with probiotics and/or prebiotics: a systematic review and comment by the ESPGHAN committee on nutrition. Journal of Pediatric Gastroenterology and Nutrition 2011;52(2):238‐50. [DOI: 10.1097/MPG.0b013e3181fb9e80; PUBMED: 21150647] - DOI - PubMed
Campbell 1989
    1. Campbell JP. Dietary treatment of infant colic: a double‐blind study. Journal of the Royal College of General Practitioners 1989;39(318):11‐4. [PUBMED: 2553940] - PMC - PubMed
Campbell 2000
    1. Campbell M, Grimshaw J, Steen N. Sample size calculations for cluster randomised trials. Changing Professional Practice in Europe Group (EU BIOMED II Concerted Action). Journal of Health Services Research & Policy 2000;5(1):12‐6. [PUBMED: 10787581] - PubMed
Clifford 2002
    1. Clifford TJ, Campbell MK, Speechley KN, Gorodzinsky F. Infant colic: empirical evidence of the absence of an association with source of early infant nutrition. Archives of Pediatrics & Adolescent Medicine 2002;156(11):1123‐8. [PUBMED: 12413341] - PubMed
de Weerth 2013
    1. Weerth C, Fuentes S, Puylaert P, Vos WM. Intestinal microbiota of infants with colic: development and specific signatures. Pediatrics 2013;131(2):e550‐8. [DOI: 10.1542/peds.2012-1449] - DOI - PubMed
Deeks 2011
    1. Deeks JJ, Higgins JP, Altman DG. Chapter 9: Analysing data and undertaking meta‐analyses. In: Higgins JP, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
Deshpande 2010
    1. Deshpande G, Rao S, Patole S, Bulsara M. Updated meta‐analysis of probiotics for preventing necrotizing enterocolitis in preterm neonates. Pediatrics 2010;125(5):921‐30. [DOI: 10.1542/peds.2009-1301] - DOI - PubMed
Deshpande 2011
    1. Deshpande GC, Rao SC, Keil AD, Patole SK. Evidence‐based guidelines for use of probiotics in preterm neonates. BMC Medicine 2011;9:92. [DOI: 10.1186/1741-7015-9-92; PMC3163616] - DOI - PMC - PubMed
Drossman 2016
    1. Drossman DA, Hasler WL. Rome IV‐functional GI disorders: disorders of gut‐brain interaction. Gastroenterology 2016;150(6):1257‐61. [DOI: 10.1053/j.gastro.2016.03.035; PUBMED: 27147121] - DOI - PubMed
Dupont 2010
    1. Dupont C, Rivero M, Grillon C, Belaroussi N, Kalindjian A, Marin V. Alpha‐lactalbumin‐enriched and probiotic‐supplemented infant formula in infants with colic: growth and gastrointestinal tolerance. European Journal of Clinical Nutrition 2010;64(7):765‐7. [DOI: 10.1038/ejcn.2010.81; PUBMED: 20517331] - DOI - PubMed
Estep 2000
    1. Estep DC, Kulczycki A Jr. Treatment of infant colic with amino acid‐based infant formula: a preliminary study. Acta Paediatrica 2000;89(1):22‐7. [PUBMED: 10677052] - PubMed
Freedman 2009
    1. Freedman SB, Al‐Harthy N, Thull‐Freedman J. The crying infant: diagnostic testing and frequency of serious underlying disease. Pediatrics 2009;123(3):841‐8. [DOI: 10.1542/peds.2008-0113; PUBMED: 19255012] - DOI - PubMed
Garrison 2000
    1. Garrison MM, Christakis DA. A systematic review of treatments for infant colic. Pediatrics 2000;106(1 Pt 2):184‐90. [PUBMED: 10888690] - PubMed
Gordon 2012
    1. Gordon M, Harper V, Thomas AG, Akobeng A. Bowel preparation for paediatric colonoscopy. Cochrane Database of Systematic Reviews 2012, Issue 7. [DOI: 10.1002/14651858.CD009976] - DOI
GRADEpro GDT [Computer program]
    1. McMaster University (developed by Evidence Prime). GRADEpro GDT. Version accessed prior to 18 June 2018. Hamilton (ON): McMaster University (developed by Evidence Prime), 2015.
Grönlund 1999
    1. Grönlund MM, Lehtonen OP, Eerola E, Kero P. Fecal microflora in healthy infants born by different methods of delivery: permanent changes in intestinal flora after cesarean delivery. Journal of Pediatric Gastroenterology and Nutrition 1999;28(1):19‐25. [PUBMED: 9890463] - PubMed
Gupta 2007
    1. Gupta SK. Update on infantile colic and management options. Current Opinion in Investigational Drugs 2007;8(11):921‐6. [PUBMED: 17979025] - PubMed
Gutiérrez‐Castrellón 2017
    1. Gutiérrez‐Castrellón P, Indrio F, Bolio‐Galvis A, Jiménez‐Gutiérrez C, Jimenez‐Escobar I, López‐Velázquez G. Efficacy of Lactobacillus reuteri DSM 17938 for infantile colic: systematic review with network meta‐analysis. Medicine 2017;96(51):e9375. [DOI: 10.1097/MD.0000000000009375; PMC5758237; PUBMED: 29390535] - DOI - PMC - PubMed
Guyatt 2008
    1. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck‐Ytter Y, GRADE Working Group, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336(7650):924‐6. [DOI: 10.1136/bmj.39489.470347.AD] - DOI - PMC - PubMed
Hall 2012
    1. Hall B, Chesters J, Robinson A. Infantile colic: a systematic review of medical and conventional therapies. Journal of Paediatrics and Child Health 2012;48(2):128‐37. [DOI: 10.1111/j.1440-1754.2011.02061.x; PUBMED: 21470331] - DOI - PubMed
Heine 2013
    1. Heine RG. Cow's‐milk allergy and lactose malabsorption in infants with colic. Journal of Paediatric Gastroenterology and Nutrition 2013;57(Suppl 1):S25‐7. [DOI: 10.1097/01.mpg.0000441930.13307.9b] - DOI
Heine 2014
    1. Heine RG, Hill DJ, Hoskin CS. Infantile colic and food allergy. In: Metcalfe DD, Sampson HA, Simon RA, Lack G editor(s). Food Allergy: Adverse Reactions to Foods and Food Additives. 5th Edition. Chichester: John Wiley & Sons, 2014:171‐81. [DOI: 10.1002/9781118744185.ch15] - DOI
Higgins 2011a
    1. Higgins JP, Deeks JJ. Chapter 7: Selecting studies and collecting data. In: Higgins JP, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
Higgins 2011b
    1. Higgins JP, Deeks JJ, Altman DG. Chapter 16: Special topics in statistics. In: Higgins JP, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
Hill 1995
    1. Hill DJ, Hudson IL, Sheffield LJ, Shelton MJ, Menahem S, Hosking CS. A low allergen diet is a significant intervention in infantile colic: results of a community‐based study. Journal of Allergy and Clinical Immunology 1995;96(6 Pt 1):886‐92. [DOI: 10.1016/S0091-6749(95)70224-5; PUBMED: 8543745] - DOI - PubMed
Hill 2000
    1. Hill DJ, Hosking CS. Infantile colic and food hypersensitivity. Journal of Pediatric Gastroenterology and Nutrition 2000;30 Suppl(1):S67‐76. [PUBMED: 10634302] - PubMed
Hill 2005
    1. Hill DJ, Roy N, Heine RG, Hosking CS, Francis DE, Brown J, et al. Effect of a low‐allergen maternal diet on colic among breastfed infants: a randomized, controlled trial. Pediatrics 2005;116(5):e709‐15. [DOI: 10.1542/peds.2005-0147; PUBMED: 16263986] - DOI - PubMed
Houghteling 2015
    1. Houghteling PD, Walker WA. Why is initial bacterial colonization of the intestine important to infants' and children's health?. Journal of Paediatric Gastroenterology and Nutrition 2015;60(3):294‐307. [DOI: 10.1097/MPG.0000000000000597; PMC4340742; PUBMED: 25313849] - DOI - PMC - PubMed
Hyams 1989
    1. Hyams JS, Geertsma MA, Etienne NL, Treem WR. Colonic hydrogen production in infants with colic. Journal of Pediatrics 1989;115(4):592‐4. [PUBMED: 2795353] - PubMed
Hyman 2006
    1. Hyman PE, Milla PJ, Benninga MA, Davidson GP, Fleisher DF, Taminiau J. Childhood functional gastrointestinal disorders: neonate/toddler. Gastroenterology 2006;130(5):1519‐26. [DOI: 10.1053/j.gastro.2005.11.065; PUBMED: 16678565] - DOI - PubMed
Iacono 1991
    1. Iacono G, Carroccio A, Montalto G, Cavataio F, Bragion E, Lorello D, et al. Severe infantile colic and food intolerance: a long‐term prospective study. Journal of Pediatric Gastroenterology and Nutrition 1991;12(3):332‐5. [PUBMED: 2072224] - PubMed
Iacono 2005
    1. Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Prima L, et al. Gastrointestinal symptoms in infancy: a population‐based prospective study. Digestive and Liver Disease 2005;37(6):432‐8. [DOI: 10.1016/j.dld.2005.01.009; PUBMED: 15893282] - DOI - PubMed
Iacovou 2012
    1. Iacovou M, Ralston RA, Muir J, Walker KZ, Truby H. Dietary management of infantile colic: a systematic review. Maternal and Child Health Journal 2012;16(6):1319‐31. [DOI: 10.1007/s10995-011-0842-5; PUBMED: 21710185] - DOI - PubMed
Infante 2011
    1. Infante D, Segarra O, Luyer BL. Dietary treatment of colic caused by excess gas in infants: biochemical evidence. World Journal of Gastroenterology 2011;17(16):2104‐8. [DOI: 10.3748/wjg.v17.i16.2104; PMC3084395; PUBMED: 21547129] - DOI - PMC - PubMed
Jakobsson 1983
    1. Jakobsson I, Lindberg T. Cow's milk proteins cause infantile colic in breast‐fed infants: a double‐blind crossover study. Pediatrics 1983;71(2):268‐71. - PubMed
Jakobsson 2000
    1. Jakobsson I, Lothe L, Ley D, Borschel MW. Effectiveness of casein hydrolysate feedings in infants with colic. Acta Paediatrica 2000;89(1):18‐21. [PUBMED: 10677051] - PubMed
Kanabar 2001
    1. Kanabar D, Randhawa M, Clayton P. Improvement of symptoms in infant colic following reduction of lactose load with lactase. Journal of Human Nutrition and Dietetics 2001;14(5):359‐63. [PUBMED: 11906576] - PubMed
Landgren 2011
    1. Landgren K, Hallström I. Parents' experience of living with a baby with infantile colic – a phenomenological hermeneutic study. Scandinavian Journal of Caring Sciences 2011;25(2):317‐24. [DOI: 10.1111/j.1471-6712.2010.00829.x; PUBMED: 20723153] - DOI - PubMed
Lederberg 2001
    1. Lederberg J, McCray AT. 'Ome Sweet 'Omics – a genealogical treasury of words. www.the‐scientist.com/?articles.view/articleNo/13313/title/‐Ome‐Sweet‐‐Omics‐‐‐A... (accessed 7 December 2016).
Lindberg 1999
    1. Lindberg T. Infantile colic and small intestinal function: a nutritional problem?. Acta Paediatrica 1999;88(430):58‐60. - PubMed
Lothe 1982
    1. Lothe L, Lindberg T, Jakobsson I. Cow's milk formula as a cause of infantile colic: a double‐blind study. Pediatrics 1982;70(1):7‐10. [PUBMED: 7088636] - PubMed
Lothe 1989
    1. Lothe L, Lindberg T. Cow's milk whey protein elicits symptoms of infantile colic in colicky formula‐fed infants: a double‐blind crossover study. Pediatrics 1989;83(2):262‐6. [PUBMED: 2913556] - PubMed
Lucas 1998
    1. Lucas A, James‐Roberts I. Crying, fussing and colic behaviour in breast‐ and bottle‐fed infants. Early Human Development 1998;53(1):9‐18. [PUBMED: 10193923] - PubMed
Lucassen 2000
    1. Lucassen PL, Assendelft WJ, Gubbels JW, Eijk JT, Douwes AC. Infantile colic: crying time reduction with a whey hydrolysate: a double‐blind, randomized, placebo‐controlled trial. Pediatrics 2000;106(6):1349‐54. [PUBMED: 11099588] - PubMed
Merras‐Salmio 2013
    1. Merras‐Salmio L, Pelkonen AS, Kolho KL, Kuitunen M, Mäkelä MJ. Cow's milk‐associated gastrointestinal symptoms evaluated using the double‐blind, placebo‐controlled food challenge. Journal of Paediatric Gastroenterology and Nutrition 2013;57(3):281‐6. [DOI: 10.1097/MPG.0b013e3182993fe0; PUBMED: 23974059] - DOI - PubMed
Milidou 2012
    1. Milidou I, Henriksen TB, Jensen MS, Olsen J, Søndergaard C. Nicotine replacement therapy during pregnancy and infantile colic in the offspring. Pediatrics 2012;129(3):e652‐8. [DOI: 10.1542/peds.2011-2281] - DOI - PubMed
Miller 1990
    1. Miller JJ, Brand JC, McVeagh P. Breath hydrogen excretion in infants with colic. Archives of Disease in Childhood 1990;65(2):248. [PMC1792219] - PMC - PubMed
Moher 2009
    1. Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta‐analyses: the PRISMA statement. Annals of Internal Medicine 2009;151(4):264‐9. [PUBMED: 19622511] - PubMed
Moore 1988
    1. Moore DJ, Robb TA, Davidson GP. Breath hydrogen response to milk containing lactose in colicky and noncolicky infants. Journal of Pediatrics 1988;113(6):979‐84. [PUBMED: 3193321] - PubMed
Naidoo 2011
    1. Naidoo K, Gordon M, Fagbemi AO, Thomas AG, Akobeng AK. Probiotics for maintenance of remission in ulcerative colitis. Cochrane Database of Systematic Reviews 2011, Issue 12. [DOI: 10.1002/14651858.CD007443.pub2] - DOI - PubMed
NHS England Breastfeeding Initiation Q1 2015/16
    1. NHS England Statistical Release Breastfeeding Initiation & Breastfeeding Prevalence 6‐8 weeks: Quarter 1 2015/16. www.england.nhs.uk/statistics/wp‐content/uploads/sites/2/2014/03/Breastf... (accessed 1 May 2018).
NHS Maternity Statistics, England 2014‐15
    1. Health and Social Care Information Centre. Hospital Episode Statistics: NHS Maternity Statistics – England, 2014‐15. content.digital.nhs.uk/catalogue/PUB19127/nhs‐mate‐eng‐2014‐15‐summ‐repo... (accessed 1 May 2018).
Oozeer 2013
    1. Oozeer R, Limpt K, Ludwig T, Ben Amor K, Martin R, Wind RD, et al. Intestinal microbiology in early life: specific prebiotics can have similar functionalities as human‐milk oligosaccharides. American Journal of Clinical Nutrition 2013;98(2):561S‐71S. [DOI: 10.3945/ajcn.112.038893] - DOI - PubMed
Oxman 1992
    1. Oxman AD, Guyatt GH. A consumer's guide to subgroup analyses. Annals of Internal Medicine 1992;116(1):78‐84. [PUBMED: 1530753] - PubMed
Perry 2011
    1. Perry R, Hunt K, Ernst E. Nutritional supplements and other complementary medicines for infantile colic: a systematic review. Pediatrics 2011;127(4):720‐33. [DOI: 10.1542/peds.2010-2098; PUBMED: 21444591] - DOI - PubMed
Pitkin 1999
    1. Pitkin RM, Branagan MA, Burmeister LF. Accuracy of data in abstracts of published research articles. JAMA 1999;281(12):1110‐1. [PUBMED: 10188662] - PubMed
Praveen 2014
    1. Praveen V, Praveen S, Deshpande G, Patole SK. Oral probiotics for infantile colic. Cochrane Database of Systematic Reviews 2014, Issue 3. [DOI: 10.1002/14651858.CD010986] - DOI
Reijneveld 2001
    1. Reijneveld SA, Brugman E, Hirasing RA. Excessive infant crying: the impact of varying definitions. Pediatrics 2001;108(4):893‐7. [PUBMED: 11581441] - PubMed
Review Manager 2014 [Computer program]
    1. Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager 5 (RevMan 5). Version 5.3. Copenhagen: Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
Rijkers 2011
    1. Rijkers GT, Vos WM, Brummer RJ, Morelli L, Corthier G, Marteau P. Health benefits and health claims of probiotics: bridging science and marketing. British Journal of Nutrition 2011;106(9):1291‐6. [DOI: 10.1017/S000711451100287X; PUBMED: 21861940] - DOI - PubMed
Roberfroid 2007
    1. Roberfroid M. Prebiotics: the concept revisited. Journal of Nutrition 2007;137(3 Suppl 2):830S‐7S. [PUBMED: 17311983] - PubMed
Romanello 2013
    1. Romanello S, Spiri D, Marcuzzi E, Zanin A, Boizeau P, Riviere S, et al. Association between childhood migraine and history of infantile colic. JAMA 2013;309(15):1607‐12. [DOI: 10.1001/jama.2013.747; PUBMED: 23592105] - DOI - PubMed
Saps 2011
    1. Saps M, Lu P, Bonilla S. Cow's‐milk allergy is a risk factor for the development of FGIDs in children. Journal of Pediatric Gastroenterology and Nutrition 2011;52(2):166‐9. [DOI: 10.1097/MPG.0b013e3181e85b55; PUBMED: 20975580] - DOI - PubMed
Savino 2001
    1. Savino F, Cresi F, Silvestro L, Oggero R. Use of an amino‐acid formula in the treatment of colicky breastfed infants. Acta Paediatrica 2001;90(3):359‐60. [PUBMED: 11332183] - PubMed
Savino 2005
    1. Savino F, Castagno E, Bretto R, Brondello C, Palumeri E, Oggero R. A prospective 10‐year study on children who had severe infantile colic. Acta Paediatrica Supplement 2005;94(449):129‐32. [DOI: 10.1080/08035320510043691; PUBMED: 16214780] - DOI - PubMed
Savino 2006
    1. Savino F, Palumeri E, Castagno E, Cresi F, Dalmasso P, Cavallo F, et al. Reduction of crying episodes owing to infantile colic: a randomized controlled study on the efficacy of a new infant formula. European Journal of Clinical Nutrition 2006;60(11):1304‐10. [DOI: 10.1038/sj.ejcn.1602457; PUBMED: 16736065] - DOI - PubMed
Savino 2007a
    1. Savino F. Focus on infantile colic. Acta Paediatrica 2007;96(9):1259‐64. [DOI: 10.1111/j.1651-2227.2007.00428.x; PUBMED: 17718777] - DOI - PubMed
Savino 2007b
    1. Savino F, Pelle E, Palumeri E, Oggero R, Miniero R. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics 2007;119(1):e124‐30. [DOI: 10.1542/peds.2006-1222] - DOI - PubMed
Savino 2010a
    1. Savino F, Tarasco V. New treatments for infant colic. Current Opinion in Pediatrics 2010;22(6):791‐7. [DOI: 10.1097/MOP.0b013e32833fac24; PUBMED: 20859207] - DOI - PubMed
Savino 2010b
    1. Savino F, Cordisco L, Tarasco V, Palumeri E, Calabrese R, Oggero R, et al. Lactobacillus reuteri DSM 17938 in infantile colic: a randomized, double‐blind, placebo‐controlled trial. Pediatrics 2010;126(3):e526‐33. [DOI: 10.1542/peds.2010-0433; PUBMED: 20713478] - DOI - PubMed
Savino 2012
    1. Savino F, Tarasco V, Lingua C, Moja L, Ricceri F. Pain‐relieving agents for infant colic. Cochrane Database of Systematic Reviews 2012, Issue 7. [DOI: 10.1002/14651858.CD009999] - DOI - PMC - PubMed
Savino 2013a
    1. Savino F, Juncker A, Opramolla A, Tarasco V, Ceratto S, Bonde I, et al. Metagenomic analysis of fecal samples from healthy and colicky infants. Journal of Paediatric Gastroenterology and Nutrition 2013;56(2):154.
Savino 2013b
    1. Savino F, Ceratto S, Opramolla A, Locatelli E, Tarasco V, Amaretti A, et al. Coliforms and infant colic: fish analysis of fecal samples of breastfed and formula fed infants. Journal of Paediatric Gastroenterology and Nutrition 2013;56(2):472.
Savino 2014
    1. Savino F, Tarasco V, Sorrenti M, Lingua C, Moja L, Gordon M, et al. Dietary modifications for infantile colic. Cochrane Database of Systematic Reviews 2014, Issue 3. [DOI: 10.1002/14651858.CD011029] - DOI - PMC - PubMed
Schach 2002
    1. Schach B, Haight M. Colic and food allergy in the breastfed infant: is it possible for an exclusively breastfed infant to suffer from food allergy?. Journal of Human Lactation 2002;18(1):50‐2. [DOI: 10.1177/089033440201800108] - DOI - PubMed
Shannon 1921
    1. Shannon WR. Colic in breast‐fed infants as a result of sensitization to foods in the mother's diet. Archives Paediatrica 1921;38:756‐61.
Sterne 2011
    1. Sterne JA, Egger M, Moher D. Chapter 10: Addressing reporting biases. In: Higgins JP, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
Sung 2012
    1. Sung V, Hiscock H, Tang M, Mensah F, Heine RG, Stock A, et al. Probiotics to improve outcomes of colic in the community: protocol for the Baby Biotics randomised controlled trial. BMC Pediatrics 2012;12:135. [DOI: 10.1186/1471-2431-12-135; PMC3508922; PUBMED: 22928654] - DOI - PMC - PubMed
Sung 2014
    1. Sung V, Hiscock H, Tang ML, Mensah FK, Nation ML, Satzke C, et al. Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial. BMJ 2014;348:g2107. [DOI: 10.1136/bmj.g2107] - DOI - PMC - PubMed
Thomas 2010
    1. Thomas DW, Greer FR, American Academy of Pediatrics Committee on Nutrition, American Academy of Pediatrics Section on Gastroenterology, Hepatology, Nutrition. Probiotics and prebiotics in pediatrics. Pediatrics 2010;126(6):1217‐31. [DOI: 10.1542/peds.2010-2548; PUBMED: 21115585] - DOI - PubMed
Vandenplas 2015
    1. Vandenplas Y, Abkari A, Bellaiche M, Benninga M, Chouraqui JP, Çokura F, et al. Prevalence and health outcomes of functional gastrointestinal symptoms in infants from birth to 12 months of age. Journal of Pediatric Gastroenterology and Nutrition 2015;61(5):531‐7. [DOI: 10.1097/MPG.0000000000000949; PMC4631121; PUBMED: 26308317] - DOI - PMC - PubMed
Walter 2000
    1. Walter SD. Choice of effect measure for epidemiological data. Journal of Clinical Epidemiology 2000;53(9):931‐9. [PUBMED: 11004419] - PubMed
Wessel 1954
    1. Wessel MA, Cobb JC, Jackson EB, Harris GS Jr, Detwiler AC. Paroxysmal fussing in infancy, sometimes called colic. Pediatrics 1954;14(5):421‐35. [PUBMED: 13214956] - PubMed
Wolke 2017
    1. Wolke D, Bilgin A, Samara M. Systematic review and meta‐analysis: fussing and crying durations and prevalence of colic in infants. Journal of Pediatrics 2017;185:55‐61. [DOI: 10.1016/j.jpeds.2017.02.020; PUBMED: 28385295] - DOI - PubMed
Yusuf 1991
    1. Yusuf S, Wittes J, Probstfield K, Tyroler HA. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 1991;266(1):93‐8. [PUBMED: 2046134] - PubMed

References to other published versions of this review

Banks 2016
    1. Banks SS, Thomas MR, Gordon M, Wallace C, Akobeng AK. Probiotics to prevent infantile colic. Cochrane Database of Systematic Reviews 2016, Issue 12. [DOI: 10.1002/14651858.CD012473] - DOI - PMC - PubMed

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