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Meta-Analysis
. 2018 Oct 10;10(10):CD011029.
doi: 10.1002/14651858.CD011029.pub2.

Dietary modifications for infantile colic

Morris Gordon  1 , Elena Biagioli, Miriam Sorrenti, Carla Lingua, Lorenzo Moja, Shel Sc Banks, Simone Ceratto, Francesco Savino
Affiliations
Meta-Analysis

Dietary modifications for infantile colic

Morris Gordon 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. This condition appears to be more frequent in the first six weeks of life (prevalence range of 17% to 25%), depending on the specific location reported and definitions used, and it usually resolves by three months of age. The aetiopathogenesis of infantile colic is unclear but most likely multifactorial. A number of psychological, behavioural and biological components (food hypersensitivity, allergy or both; gut microflora and dysmotility) are thought to contribute to its manifestation. The role of diet as a component in infantile colic remains controversial.

Objectives: To assess the effects of dietary modifications for reducing colic in infants less than four months of age.

Search methods: In July 2018 we searched CENTRAL, MEDLINE, Embase , 17 other databases and 2 trials registers. We also searched Google, checked and handsearched references and contacted study authors.

Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs evaluating the effects of dietary modifications, alone or in combination, for colicky infants younger than four months of age versus another intervention or placebo. We used specific definitions for colic, age of onset and the methods for performing the intervention. We defined 'modified diet' as any diet altered to include or exclude certain components.

Data collection and analysis: We used standard methodological procedures expected by Cochrane. Our primary outcome was duration of crying, and secondary outcomes were response to intervention, frequency of crying episodes, parental/family quality of life, infant sleep duration, parental satisfaction and adverse effects.

Main results: We included 15 RCTs involving 1121 infants (balanced numbers of boys and girls) aged 2 to 16 weeks. All studies were small and at high risk of bias across multiple design factors (e.g. selection, attrition). The studies covered a wide range of dietary interventions, and there was limited scope for meta-analysis. Using the GRADE approach, we assessed the quality of the evidence as very low.Low-allergen maternal diet versus a diet containing known potential allergens: one study (90 infants) found that 35/47 (74%) of infants responded to a low-allergen maternal diet, compared with 16/43 (37%) of infants on a diet containing known potential allergens.Low-allergen diet or soy milk formula versus dicyclomine hydrochloride: one study (120 infants) found that 10/15 (66.6%) breastfed babies responded to dicyclomine hydrochloride, compared with 24/45 (53.3%) formula-fed babies. There was little difference in response between breastfed babies whose mother changed their diet (10/16; 62.5%) and babies who received soy milk formula (29/44; 65.9%).Hydrolysed formula versus standard formula: two studies (64 infants) found no difference in duration of crying, reported as a dichotomous outcome: risk ratio 2.03, 95% confidence interval (CI) 0.81 to 5.10; very low-quality evidence. The author of one study confirmed there were no adverse effects. One study (43 infants) reported a greater reduction in crying time postintervention with hydrolysed formula (104 min/d, 95% CI 55 to 155) than with standard formula (3 min/d, 95% CI -63 to 67).Hydrolysed formula versus another hydrolysed formula: one study (22 infants) found that two types of hydrolysed formula were equally effective in resolving symptoms for babies who commenced with standard formula (Alimentum reduced crying to 2.21 h/d (standard deviation (SD) 0.40) and Nutramigen to 2.93 h/d (SD 0.70)).Hydrolysed formula or dairy- and soy-free maternal diet versus addition of parental education or counselling: one study (21 infants) found that crying time decreased to 2.03 h/d (SD 1.03) in the hydrolysed or dairy- and soy-free group compared with 1.08 h/d (SD 0.7) in the parent education or counselling group, nine days into the intervention.Partially hydrolysed, lower lactose, whey-based formulae containing oligosaccharide versus standard formula with simethicone: one study (267 infants) found that both groups experienced a decrease in colic episodes (secondary outcome) after seven days (partially hydrolysed formula: from 5.99 episodes (SD 1.84) to 2.47 episodes (SD 1.94); standard formula: from 5.41 episodes (SD 1.88) to 3.72 episodes (SD 1.98)). After two weeks the difference between the two groups was significant (partially hydrolysed: 1.76 episodes (SD 1.60); standard formula: 3.32 episodes (SD 2.06)). The study author confirmed there were no adverse effects.Lactase enzyme supplementation versus placebo: three studies (138 infants) assessed this comparison, but none reported data amenable to analysis for any outcome. There were no adverse effects in any of the studies.Extract of Foeniculum vulgare, Matricariae recutita, and Melissa officinalis versus placebo: one study (93 infants) found that average daily crying time was lower for infants given the extract (76.9 min/d (SD 23.5), than infants given placebo (169.9 min/d (SD 23.1), at the end of the one-week study. There were no adverse effects.Soy protein-based formula versus standard cows' milk protein-based formula: one study (19 infants) reported a mean crying time of 12.7 h/week (SD 16.4) in the soy formula group versus 17.3 h/week (SD 6.9) in the standard cows' milk group, and that 5/10 (50%) responded in the soy formula group versus 0/9 (0%) in the standard cows' milk group.Soy protein formula with polysaccharide versus standard soy protein formula: one study (27 infants) assessed this comparison but did not provide disaggregated data for the number of responders in each group after treatment.No study reported on our secondary outcomes of parental or family quality of life, infant sleep duration per 24 h, or parental satisfaction.

Authors' conclusions: Currently, evidence of the effectiveness of dietary modifications for the treatment of infantile colic is sparse and at significant risk of bias. The few available studies had small sample sizes, and most had serious limitations. There were insufficient studies, thus limiting the use of meta-analysis. Benefits reported for hydrolysed formulas were inconsistent.Based on available evidence, we are unable to recommend any intervention. Future studies of single interventions, using clinically significant outcome measures, and appropriate design and power are needed.

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Conflict of interest statement

Morris Gordon (MG) received travel grants from a number of companies during the three years leading up to publication, including from Allergan, Ferring Pharmaceuticals, Biogaia, Synergy and Tillots, to attend conferences (Advances in Inflammatory Bowel Disease, Digestive Disease Week, World Congress of Gastroentrology) and present the results of other Cochrane Reviews. These companies have had no input or involvement in any aspect of the review process during this, or previous systematic reviews carried out by MG. MG currently holds a National Institute for Health Research (NIHR) Cochrane Programme Grant, although this did not support this work. MG is a paediatrician with an interest in gastroenterology. This involves seeing patients referred with infantile colic and managing their condition in line with current, accepted, evidence‐based practice. MG has no other interests to declare.

Elena Biagioli – none known.

Miriam Sorrenti – none known.

Carla Lingua – none known.

Lorenzo Moja – none known.

Shel Banks (SB) is self‐employed as an Internationally Board Certified Lactation Consultant in private practice, delivering expertise in infant feeding evidence base, writing briefing papers and newsletters, etc., and delivering workshops across the northwest of England – largely for the Local Infant Feeding Information Board (LIFIB), but also the Sudden Unexpected Death of a Child (SUDC) prevention team, Lanacshire. Until March 2016, the SUDC consultant post was funded by the local authority (Lancashire County Council) via breastfeeding voluntary sector charity (Breastfeeding Network) and SB was paid by the hour. SB is also self‐employed as a trainer and webinar presenter ad hoc and delivers Babyem's Open College Network Level Three and Four Maternity Nurse Training courses. Since 2009, SB has worked part‐time as a Baby Friendly Co‐ordinator, and she was paid for 12 months by Blackpool Teaching Hospitals NHS Foundation Trust as a Research Assistant for her work on this review. SB is Chair of LIFIB, Chair of the Communications Team, Chair of the Breastfeeding Festival, Committee Member of the Lactation Consultants of Great Britain, and a Trustee of the UK Association of Milk Banking, all of which are voluntary positions, although SB's travel expenses to meetings are paid. SB received travel expenses from Manchester City Council for speaking at their event 'Make Manchester a Breastfeeding Friendly City' in June 2018. SB has sat as a lay member on the Guideline Development Committee of three NICE Guidelines (Milk Banking, Postnatal Care Quality Standards and Faltering Growth), and was paid an honorarium by NICE (National Institute for Health and Care Excellence) for her services. SB declares that neither she personally, nor any of the entities 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 Internationally Board Certified Lactation Consultant. SB has no other interests to declare.

Simone Ceratto (SC) received travel grants from Nóos S.r.l and Nestlé, to attend scientific meetings. SC declares that he attended 'Campus Angelini 2017', which was sponsored by Angelini.

Francesco Savino (FS) received payment from: Danone Nutricia Middle‐East DMCC, Dubai, United Arab Emirates, and Innova Pharma SpA Recordati SpA, Milan, Italy, for talks at symposiums; Società Italiana di Pediatria, Milan, Italy, for speaking at the XX Congresso Nazionale SIAIP, sponsored by Biomedia srl, Milan; HiPP GmbH & Co, Vertrieb KG, Pfaffenhofen, Germany, for consultancy work; and from Aretrè srl, Milan, Italy, for development of educational materials, outside the submitted work. FS also received a travel grant from Noos Roma, Italy, to attend ESPGHAN's 51st Annual Meeting, Geneva, and receives royalties from Springer Verlag, Milan, Italy, for the book Nutrizione Parenterale in Pediatria. FS declares that these organizations have had no input or involvement in any aspect of the review process during this, or previous systematic review that he has carried out. FS has no other interests to declare.

Disclaimer: the views contained herein are those of the authors and not necessarily those of the Department of Health, NHS NICE or NIHR.

Figures

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1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
See this image and copyright information in PMC

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References to ongoing studies

NCT01721850 {unpublished data only}
    1. NCT01721850. Evaluation of safety and efficacy of new infant formula in infantile colic (Coco) [Evaluation of the safety and efficacy of new infant formula and its effects on the gastrointestinal tolerance (crying time) in infantile colic: a double‐blind, randomized, controlled intervention study]. clinicaltrials.gov/ct2/show/NCT01721850 (first received 6 November 2012).
NCT02813772 {unpublished data only}
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NCT03329222 {unpublished data only}
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