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Review
. 2025 Jul 10;7(7):CD015875.
doi: 10.1002/14651858.CD015875.

Gut microbiome-based interventions for the management of obesity in children and adolescents aged up to 19 years

Affiliations
Review

Gut microbiome-based interventions for the management of obesity in children and adolescents aged up to 19 years

Shah Mohammad Fahim et al. Cochrane Database Syst Rev. .

Abstract

Background: The epidemic of overweight and obesity affects more than 390 million children and adolescents aged 5 to 19 years and 37 million children under five years of age. Overweight and obesity are associated with both short- and long-term consequences, including chronic inflammation, metabolic diseases, as well as alterations in the gut microbiome composition. Gut microbiome-based approaches may impact microbiome-related metrics such as diversity or the abundance of intestinal bacteria, which may be linked to obesity-related outcomes. However, evidence regarding the effect of gut microbiome-based interventions for the management of obesity is limited.

Objectives: To assess the effects of gut microbiome-based interventions in the management of overweight or obesity in children and adolescents in all their diversity aged 0 to 19 years.

Search methods: We searched CENTRAL, MEDLINE, CINAHL, Web of Science Core Collection, BIOSIS Previews, Global Index Medicus (all regions), IBECS, SciELO, PAHO, PAHO IRIS, WHO IRIS, WHOLIS, Bibliomap, TRoPHI as well as ICTRP Search Portal and ClinicalTrials.gov. The date of the last search for all databases was 24 January 2025. We did not apply any language restrictions.

Selection criteria: We included randomised controlled trials that evaluated gut microbiome-based interventions [i.e. prebiotics, probiotics, synbiotics, short-chain fatty acids (SCFAs), and faecal microbiota transplantation (FMT)] compared to standard-of-care, placebo, or control interventions in children and adolescents aged 0 to 19 years with overweight or obesity.

Data collection and analysis: Two review authors independently screened titles and abstracts and full texts, extracted data, and assessed the risk of bias using the Cochrane Risk of Bias 2 tool and certainty of the evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE), a framework for assessing the certainty of evidence and making recommendations in systematic reviews. Random-effects meta-analyses were performed unless only one study per outcome was available, for which fixed-effect analyses were performed.

Main results: We found 17 studies (838 participants) from various countries, evaluating the effects of prebiotics, probiotics, synbiotics, SCFAs, and FMT on body mass index (BMI), body weight, waist circumference, total body fat percentage (%TBF), systolic and diastolic blood pressure, and adverse events. Of the 17 studies included, five studies were in adolescents aged 10 to 19 years, and 12 studies were in children and adolescents spanning both age groups, 0 to 19 years. Upon contacting authors for data grouped by age of the participants, no studies provided separate outcomes data for children and adolescents. The included studies were funded by either academic funding sources or grants from the public and private sectors. Additionally, 15 studies were classified as currently being conducted ('ongoing'). The certainty of evidence throughout was very low. In adolescents 10 to 19 years of age, probiotics compared to placebo or no intervention may have little to no effect on BMI, body weight, waist circumference, %TBF, blood pressure, and adverse events. Similarly, FMT compared to placebo may have little to no effect on waist circumference, %TBF, blood pressure, and adverse events in this age group. According to one study with 41 participants and in children and adolescents 0 to 19 years of age, intervention with prebiotics compared to placebo may result in a small reduction in BMI (mean difference = -0.70, 95% CI = -1.25 to -0.15) and body weight (mean difference = -1.5, 95% CI = -2.61 to -0.39). Prebiotics compared to placebo may have little to no effect on waist circumference, %TBF, systolic blood pressure, and adverse events. No data were available on the effect of prebiotics on diastolic blood pressure. Probiotics compared to placebo may have little to no effect on BMI, body weight, waist circumference, %TBF, blood pressure, and adverse events in children and adolescents (0 to 19 years). Synbiotics compared to placebo may result in a reduction in systolic blood pressure (mean difference = -40.00, 95% CI = -50.63 to -29.37) in children and adolescents (0 to 19 years); according to one study with 56 participants. The evidence is very uncertain about the effects of synbiotics compared to a placebo on BMI, body weight, waist circumference, blood pressure, and adverse events. No data were available on the effect of synbiotics compared to placebo on %TBF. Synbiotics, compared to probiotics, may have little to no effect on waist circumference, %TBF, and adverse events. No data were available on the effect of synbiotics compared to probiotics on BMI, body weight, and blood pressure. According to one study with 48 participants and very low-certainty of evidence, SCFAs compared to placebo may result in a reduction in waist circumference (mean difference = -5.08, 95% CI = -7.40 to -2.76) and BMI (mean difference = -2.26, 95% CI = -3.24 to -1.28) in children and adolescents (0-19 years). SCFAs compared to placebo may have little to no effect on adverse events. No data were available on the effect of SCFAs on body weight, %TBF, and blood pressure. Adverse events, i.e. abdominal cramps, abdominal discomfort, abdominal pain, diarrhoea, vomiting, and migraine, were reported in the prebiotics group but with very low incidence. Additionally, adverse events such as nausea and headache were reported in the SCFAs group, but with low incidence.

Authors' conclusions: In adolescents aged 10 to 19 years, gut microbiome-based interventions may result in little to no difference in obesity-related outcomes. In children and adolescents aged 0 to 19 years, prebiotics may result in a small reduction in BMI and body weight; synbiotics may result in a reduction in systolic blood pressure, and SCFAs may result in a reduction in BMI and waist circumference, albeit the certainty of evidence was very low. The evidence was of very low certainty due to few studies per comparison, small sample sizes, short intervention durations, and insufficient reporting of adverse events. More rigorous research examining different types of gut microbiome-based interventions for the management of obesity is required in children and adolescents, both in clinical and community settings. Future trials should also report methods related to randomisation, blinding, and compliance, as well as include prespecified analysis plans.

Trial registration: ClinicalTrials.gov NCT04578652.

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Conflict of interest statement

SMF: none known;

SLH: none known;

XPM: none known;

NA: has no known conflicts of interest to declare. NA worked at Natural Remedies Pvt. Ltd., Bangalore, India as a Management Trainee for a total of three years with the date of resignation being December 2020. The company manufactures herbal medicine and food for both animal and human use. The company was started by her grandfather and is run by her father and uncle. She holds no shares, gets no money, or doesn't own any part of the company.

PR: none known;

NJ: none known;

MK: none known;

RK: none known;

JLF: has no known conflicts of interest to declare. JLF is a principal investigator on research grants to examine the burden and aetiology of anaemia in women of reproductive age (U.S. Centers for Disease Control and Prevention), biomarkers of nutritional status in women of reproductive age (National Institutes of Health), and to conduct randomised trials with micronutrient interventions to improve the health of women of reproductive age (U.S. Centers for Disease Control and Prevention). JLF is a Cochrane Editor, but was not involved in the editorial process for this review.

SM: has no conflicts of interest to declare. In the interest of full disclosure, SM holds equity in VitaScan, a startup company, aiming to commercialise some of his research on point‐of‐care assessment of nutritional status as a faculty member at Cornell University.

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References

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Kjølbæk 2020 {published data only}
    1. Kjølbæk L, Benítez-Páez A, Gómez Del Pulgar EM, Brahe LK, Liebisch G, Matysik S, et al. Arabinoxylan oligosaccharides and polyunsaturated fatty acid effects on gut microbiota and metabolic markers in overweight individuals with signs of metabolic syndrome: a randomized cross-over trial. Clinical Nutrition (Edinburgh, Scotland) 2020;39(1):67‐79. [DOI: 10.1016/j.clnu.2019.01.012] - DOI - PubMed
Lammi 2024 {published data only}
    1. Lammi C, Ottaviano E, Fiore G, Bollati C, D'Adduzio L, Fanzaga M, et al. Effect of docosahexaenoic acid as an anti-inflammatory for Caco-2 cells and modulating agent for gut microbiota in children with obesity (the DAMOCLE study). Journal of Endocrinological Investigation 2024;48:465–81. [DOI: 10.1007/s40618-024-02444-w] - DOI - PMC - PubMed
Li 2021 {published data only}
    1. Li H, Wu G, Zhao L, Zhang M. Suppressed inflammation in obese children induced by a high-fiber diet is associated with the attenuation of gut microbial virulence factor genes. Virulence 2021;12(1):1754-70. [DOI: 10.1080/21505594.2021.1948252] - DOI - PMC - PubMed
Li 2021a {published data only}
    1. Li H, Zhao L, Zhang M. Gut microbial SNPs induced by high-fiber diet dominate nutrition metabolism and environmental adaption of Faecalibacterium prausnitzii in obese children. Frontiers in Microbiology 2021;12:683714. [DOI: 10.3389/fmicb.2021.683714] - DOI - PMC - PubMed
Liber 2014 {published data only}
    1. Liber A, Szajewska H. Effect of oligofructose supplementation on body weight in overweight and obese children: a randomised, double-blind, placebo-controlled trial. British Journal of Nutrition 2014;112(12):2068-74. [DOI: 10.1017/S0007114514003110] - DOI - PubMed
Lind 2019 {published data only}
    1. Lind T, Johansson U, Öhlund I, Lindberg L, Lönnerdal B, Tennefors C, et al. Study protocol: optimized complementary feeding study (OTIS): a randomized controlled trial of the impact of a protein-reduced complementary diet based on Nordic foods. BMC Public Health 2019;19(1):134. [DOI: 10.1186/s12889-019-6466-1] - DOI - PMC - PubMed
Macknin 2015 {published data only}
    1. Macknin M, Kong T, Weier A, Worley S, Tang AS, Alkhouri N, et al. Low fat vegan or American Heart Association diets & cardiovascular risk in obese 9-18 y.o. with elevated cholesterol [Plant-based, no-added-fat or American Heart Association diets: impact on cardiovascular risk in obese children with hypercholesterolemia and their parents]. Journal of Pediatrics 2015;166(4):953-9. [DOI: 10.1016/j.jpeds.2014.12.058] - DOI - PMC - PubMed
McCann 2021 {published data only}
    1. McCann JR, Bihlmeyer NA, Roche K, Catherine C, Jawahar J, Kwee LC, et al. The pediatric obesity microbiome and metabolism study (POMMS): methods, baseline data, and early insights. Obesity (Silver Spring, Md.) 2021;29(3):569-78. [DOI: 10.1002/oby.23081] - DOI - PMC - PubMed
Morgado 2023 {published data only}
    1. Morgado MC, Sousa M, Marques C, Coelho AB, Costa JA, Seabra A. Effects of physical activity and nutrition education on the gut microbiota in overweight and obese children. Children 2023;10(7):1242. [DOI: 10.3390/children10071242] - DOI - PMC - PubMed
Nagata 2017 {published data only}
    1. Nagata S, Chiba Y, Wang C, Yamashiro Y. The effects of the Lactobacillus casei strain on obesity in children: a pilot study. Beneficial Microbes 2017;8(4):535-43. [DOI: 10.3920/bm2016.0170] - DOI - PubMed
NCT00575991 {published data only}
    1. NCT00575991. Effect of conjugated linoleic acid on body fat in overweight children. https://clinicaltrials.gov/study/NCT00575991 (first submitted 14 December 2007).
NCT00592137 {published data only}
    1. NCT00592137. Calcium, dairy, and body fat in adolescents. https://clinicaltrials.gov/study/NCT00592137 (first submitted 26 December 2007).
NCT00631046 {published data only}
    1. NCT00631046. Essential fatty acids during complementary feeding. https://clinicaltrials.gov/study/NCT00631046 (first submitted 28 February 2008).
NCT00699413 {published data only}
    1. NCT00699413. Supplements for controlling resistance to insulin (SCORE). https://clinicaltrials.gov/study/NCT00699413 (first submitted 16 June 2008).
NCT00842543 {published data only}
    1. NCT00842543. Fruit and vegetable juice concentrate effects on RBP4 and antioxidant capacity in lean and overweight 6-10 year old boys (FVJC). https://clinicaltrials.gov/study/NCT00842543 (first submitted 11 February 2009).
NCT00858247 {published data only}
    1. NCT00858247. Effect of vitamin D3 supplementation on insulin resistance and cardiovascular risk factors in obese adolescents. https://clinicaltrials.gov/study/NCT00858247 (first submitted 5 March 2009).
NCT00937599 {published data only}
    1. NCT00937599. Brazil nut consumed on the metabolic profile, oxidative stress and nutritive microcirculatory patterns. https://clinicaltrials.gov/study/NCT00937599 (first submitted 10 July 2009).
NCT00994396 {published data only}
    1. NCT00994396. Vitamin D to improve glucose metabolism and reduce inflammation in obese adolescents. https://clinicaltrials.gov/study/NCT00994396 (first submitted 12 October 2009).
NCT01217840 {published data only}
    1. NCT01217840. Effect of vitamin D supplementation on inflammation and cardiometabolic risk factors in obese adolescents. https://clinicaltrials.gov/study/NCT01217840 (first submitted 7 October 2010).
NCT01323283 {published data only}
    1. NCT01323283. Study of omega-3 fatty acids regarding ergogenic, anti-inflammatory and obesity inhibitory effects in 8 year old children (STOPP-8 OM3). https://clinicaltrials.gov/study/NCT01323283 (first submitted 24 March 2011).
NCT01410643 {published data only}
    1. NCT01410643. Puberty related intervention to improve metabolic outcomes (the PRIMO study). https://clinicaltrials.gov/study/NCT01410643 (first submitted 30 March 2011).
NCT01456221 {published data only}
    1. NCT01456221. Intervention study with omega-3 fatty acids for weight loss and insulin resistance in adolescents (O3WLIRADOL). https://clinicaltrials.gov/study/NCT01456221 (first submitted 12 October 2011).
NCT01518803 {published data only}
    1. NCT01518803. A Mediterranean-style breakfast and postprandial lipid disorders in obese pre-adolescents and adults. https://clinicaltrials.gov/study/NCT01518803 (first submitted 23 January 2012).
NCT01650025 {published data only}
    1. NCT01650025. Effects of VSL#3 on metabolic, endocrine, lipidomic and inflammatory parameters of pediatric patients with BMI>90° (VAIIO). https://clinicaltrials.gov/study/NCT01650025 (first submitted 23 July 2012).
NCT01665742 {published data only}
    1. NCT01665742. Anti-inflammatory dietary intervention in overweight and obese adolescents. https://clinicaltrials.gov/study/NCT01665742 (first submitted 12 August 2012).
NCT01673152 {published data only}
    1. NCT01673152. The effect of the oligofructose supplementation on body weight in overweight and obese children. https://clinicaltrials.gov/study/NCT01673152 (first submitted 27 June 2012).
NCT01797302 {published data only}
    1. NCT01797302. Vitamin D and vascular health in children. https://clinicaltrials.gov/study/NCT01797302 (first submitted 20 February 2013).
NCT01934777 {published data only}
    1. NCT01934777. Efficacy and tolerance of treatment with DHA, choline and vitamin E in children with non-alcoholic steatohepatitis. https://www.clinicaltrials.gov/study/NCT01934777 (first submitted 30 August 2013).
NCT02063802 {published data only}
    1. NCT02063802. Metformin vs conjugated linoleic acid and an intervention program with healthy habits in obese children. https://www.clinicaltrials.gov/study/NCT02063802 (first submitted 12 February 2014).
NCT02117700 {published data only}
    1. NCT02117700. Fatty liver disease in obese children. https://www.clinicaltrials.gov/study/NCT02117700 (first submitted 16 April 2014).
NCT02168660 {published data only}
    1. NCT02168660. Correction of vitamin D levels and its effect on insulin resistance and weight gain in obese youth. https://www.clinicaltrials.gov/study/NCT02168660 (first submitted 17 June 2014).
NCT02948647 {published data only}
    1. NCT02948647. Healthy eating through reduction of excess sugar. https://clinicaltrials.gov/study/NCT02948647.
NCT03115385 {published data only}
    1. NCT03115385. Probiotics and the gut microbiome in obese hispanic youth. https://ClinicalTrials.gov/show/NCT03115385 (first submitted: 29 March 2017).
NCT03358524 {published data only}
    1. NCT03358524. Effects of vitamin E supplementation on free radicals and fat level of obese adolescence in Jakarta, Indonesia. https://www.clinicaltrials.gov/study/NCT03358524 (first submitted 25 November 2017).
NCT03612479 {published data only}
    1. NCT03612479. Response of the gut microbiome and circulating metabolome to diet in children: ancillary study to KIDFIT (NCT03405246). https://www.clinicaltrials.gov/study/NCT03612479 (first submitted 27 July 2018).
NCT03629119 {published data only}
    1. NCT03629119. Psylliumrx dietary fiber study. https://www.clinicaltrials.gov/study/NCT03629119 (first submitted 9 August 2018).
NCT03870984 {published data only}
    1. NCT03870984. Efficacy of nuts in obese children. https://www.clinicaltrials.gov/study/NCT03870984 (first submitted 6 March 2019).
NCT04112251 {published data only}
    1. NCT04112251. Effects of cocoa supplement in obese adolescent subjects (COOBA). https://www.clinicaltrials.gov/study/NCT04112251 (first submitted 30 September 2019).
NCT04151823 {published data only}
    1. NCT04151823. Effect of postbiotics supplementation on microbiome in obese children: the POST-OB study. https://www.clinicaltrials.gov/study/NCT04151823 (first submitted 30 October 2019).
NCT04723849 {published data only}
    1. NCT04723849. Efficacy evaluation of a mixed compound of antioxidants in terms of endothelium damage/function in pediatric subjects with obesity (OBELIX). https://www.clinicaltrials.gov/study/NCT04723849 (first submitted 14 January 2021).
NCT04770311 {published data only}
    1. NCT04770311. Childhood obesity microbiome study (CHOICE). https://www.clinicaltrials.gov/study/NCT04770311 (first submitted 23 February 2021).
NCT04783116 {published data only}
    1. NCT04783116. Plant stanols and liver inflammation in overweight and obese children. https://www.clinicaltrials.gov/study/NCT04783116 (first submitted 23 February 2021).
NCT05000775 {published data only}
    1. NCT05000775. The influence of Gniib® in obesity management in obese young individuals in Hong Kong. https://www.clinicaltrials.gov/study/NCT05000775 (first submitted 2 August 2021).
NCT05521061 {published data only}
    1. NCT05521061. The effect of human milk oligosaccharides in children with type 1 diabetes mellitus. https://www.clinicaltrials.gov/study/NCT05521061 (first submitted 15 May 2022).
NCT05671731 {published data only}
    1. NCT05671731. Combining prebiotic and diet/physical activity educational program effects on body composition and intestinal microbiota in children. https://www.clinicaltrials.gov/study/NCT05671731 (first submitted 20 December 2022).
Pi 2024 {published data only}
    1. Pi X, Du Z, Teng W, Fu H, Hu L, Li J, et al. Characteristics of stachyose-induced effects on gut microbiota and microbial metabolites in vitro associated with obesity in children. Frontiers in Nutrition 2024;11:1411374. [DOI: 10.3389/fnut.2024.1411374] - DOI - PMC - PubMed
RBR‐5h255qr {published data only}
    1. RBR-5h255qr. Response to different doses of vitamin D supplementation in individuals with obesity: a randomized clinical trial. https://ensaiosclinicos.gov.br/rg/RBR-5h255qr (first registered: 07/11/2022).
Rodrigo 2022 {published data only}
    1. Rodrigo T, Dulani S, Seneviratne SN, De Silva AP, Fernando J, De Silva HJ, et al. Effects of probiotics combined with dietary and lifestyle modification on clinical, biochemical, and radiological parameters in obese children with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis: a randomized clinical trial. Clinical and Experimental Pediatrics 2022;65(6):304‐11. [DOI: 10.3345/cep.2021.00787] - DOI - PMC - PubMed
Schmidt 2022 {published data only}
    1. NCT02948647. Healthy eating through reduction of excess sugar (HEROES). https://www.clinicaltrials.gov/study/NCT02948647 (first submitted 25 October 2016).
    1. Schmidt KA, Jones RB, Rios C, Corona Y, Berger PK, Plows JF, et al. Clinical intervention to reduce dietary sugar does not affect liver fat in Latino youth, regardless of PNPLA3 genotype: a randomized controlled trial. Journal of Nutrition 2022;152(7):1655-65. [DOI: 10.1093/jn/nxac046] - DOI - PMC - PubMed
Shestopalov 2020 {published data only}
    1. Shestopalov AV, Shatova OP, Gaponov AM, Moskaleva NE, Appolonova SA, Tutelyan AV, et al. The study of tryptophan metabolite concentrations in blood serum and fecal extracts from obese children. Biomeditsinskaya Khimiya 2020;66(6):494-501. [DOI: 10.18097/PBMC20206606494] - DOI - PubMed
SLCTR/2016/021 {published data only}
    1. SLCTR/2016/021. Effect of probiotics in the management of fatty liver disease in obese children. https://slctr.lk/trials/slctr-2016-021 (first registered: 27 Jul 2016).
UMIN000006958 {published data only}
    1. UMIN000006958. Beneficial effects of probiotics for obesity in children. https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000008198 (first submitted 27 November 2011).
Videhult 2015 {published data only}
    1. Karlsson Videhult F, Öhlund I, Stenlund H, Hernell O, West CE. Probiotics during weaning: a follow-up study on effects on body composition and metabolic markers at school age. European Journal of Nutrition 2015;54(3):355-63. [DOI: 10.1007/s00394-014-0715-y] - DOI - PubMed
Videhult 2015a {published data only}
    1. Karlsson Videhult F, Andersson Y, Öhlund I, Stenlund H, Hernell O, West CE. Impact of probiotics during weaning on the metabolic and inflammatory profile: follow-up at school age. International Journal of Food Sciences and Nutrition 2015;66(6):686-91. [DOI: 10.3109/09637486.2015.1025717] - DOI - PubMed
Vinet 2021 {published data only}
    1. NCT02400151. Vascular and metabolic effects of vitamin D supplementation associated with lifestyle management in obese adolescents (VIDADO). https://www.clinicaltrials.gov/study/NCT02400151 (first submitted 23 October 2015).
    1. Vinet A, Morrissey C, Perez-Martin A, Goncalves A, Raverdy C, Masson D, et al. Effect of vitamin D supplementation on microvascular reactivity in obese adolescents: a randomized controlled trial. Nutrition, Metabolism, and Cardiovascular Diseases 2021;31(8):2474-83. [DOI: 10.1016/j.numecd.2021.04.025] - DOI - PubMed
WANG‐Peng 2024 {published data only}
    1. Peng WA, Baoliang LI, Zhenyu HU, Yan LI, Di JI, Ping ZH. Effects of dietary restriction combined with different exercises on inflammatory factors and gut microbiota in obese children. Chinese Journal of School Health 2024;45(6):794-8. [DOI: 10.16835/j.cnki.1000-9817.2024179] - DOI
Wu 2016 {published data only}
    1. Wu G, Zhang C, Wang J, Zhang F, Wang R, Shen J, et al. Diminution of the gut resistome after a gut microbiota-targeted dietary intervention in obese children. Scientific Reports 2016;6:24030. [DOI: 10.1038/srep24030] - DOI - PMC - PubMed
Wu 2017 {published data only}
    1. Wu G, Zhang C, Wu H, Wang R, Shen J, Wang L, et al. Genomic microdiversity of Bifidobacterium pseudocatenulatum underlying differential strain-level responses to dietary carbohydrate intervention. MBio 2017;8(1):10-28. [DOI: 10.1128/mBio.02348-16] - DOI - PMC - PubMed
Xie 2021 {published data only}
    1. NCT03628937. The effect of decaffeinated green tea polyphenol intake on the risk of precocious puberty among obese girls. https://www.clinicaltrials.gov/study/NCT03628937 (first submitted 10 July 2018).
    1. Xie L, Tang Q, Yao D, Gu Q, Zheng H, Wang X, et al. Effect of decaffeinated green tea polyphenols on body fat and precocious puberty in obese girls: a randomized controlled trial. Frontiers of Endocrinology (Lausanne) 2021;12:736724. [DOI: 10.3389/fendo.2021.736724] - DOI - PMC - PubMed
Youssef 2020 {published data only}
    1. Youssef S, Singhal V, Stanford FC, Bredella M, Misra M. Differences in the gut microbiome across a range of glucose tolerance in adolescents with obesity. Hormone Research in Paediatrics 2020;93(Suppl. 1):13.
Zalewski 2019 {published data only}
    1. NCT02280772. Effect of glucomannan supplementation on body weight in overweight and obese children. https://www.clinicaltrials.gov/study/NCT02280772 (first submitted 29 October 2014).
    1. Zalewski BM, Szajewska H. Effect of glucomannan supplementation on body weight in overweight and obese children: protocol of a randomised controlled trial. BMJ Open 2015;5(4):e007244. [DOI: 10.1136/bmjopen-2014-007244] - DOI - PMC - PubMed
    1. Zalewski BM, Szajewska H. No effect of glucomannan on body weight reduction in children and adolescents with overweight and obesity: a randomized controlled trial. Journal of Pediatrics 2019;211:85-91.e1. [DOI: 10.1016/j.jpeds.2019.03.044] - DOI - PubMed
Zhou 2024 {published data only}
    1. Zhou M, Peng C, Miao Z, Wang K, Zhou H, Li Y, et al. Improved diet-based nutritional interventions can improve childhood obesity with the synergistic regulation of gut microbiota. Beneficial Microbes 2024;15(5):495-513. [DOI: 10.1163/15762591-BJA00019] - DOI - PubMed

References to studies awaiting assessment

ACTRN12616001245482 {published data only}
    1. ACTRN12616001245482. Micronutrient supplementation for improving micronutrient status in underweight and overweight/obese primary school children. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371396&... (first submitted 30 August 2016).
    1. Hoang NT, Orellana L, Gibson RS, Le TD, Worsley A, Sinclair AJ, et al. Multiple micronutrient supplementation improves micronutrient status in primary school children in Hai Phong City, Vietnam: a randomised controlled trial. Scientific Reports 2021;11(1):3728. [DOI: 10.1038/s41598-021-83129-9] - DOI - PMC - PubMed
ACTRN12617000960358 {published data only}
    1. ACTRN12617000960358. Fibre supplementation to decrease hunger, improve chronic disease risk factors and weight loss in overweight and obese children. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373193&... (first submitted 29 June 2017).
IRCT20211226053529N1 {published data only}
    1. IRCT20211226053529N1. The effect of synbiotics on reducing insulin resistance in overweight or obese children. https://irct.behdasht.gov.ir/trial/60929 (first submitted 31 December 2021).
NCT02721953 {published data only}
    1. NCT02721953. Effects of butyrate on insulin resistance in children affected by obesity. https://www.clinicaltrials.gov/study/NCT02721953 (first submitted 23 March 2016).
NCT02956408 {published data only}
    1. NCT02956408. Efficacy of vitamin D supplementation in obese children. https://www.clinicaltrials.gov/study/NCT02956408 (first submitted 3 November 2016).
NCT03139773 {published data only}
    1. NCT03139773. Nutrition intervention to measure metabolic response in children. https://www.clinicaltrials.gov/study/NCT03139773 (first submitted 8 March 2017).
NCT03196453 {published data only}
    1. NCT03196453. Fit child - clinical study on weight control (FITCHI). https://www.clinicaltrials.gov/study/NCT03196453 (first submitted 20 June 2017).
NCT03670875 {published data only}
    1. NCT03670875. Non-pharmacologic alternatives for the treatment of childhood obesity in Mexico. https://www.clinicaltrials.gov/study/NCT03670875 (first submitted 12 September 2018).
NCT04156971 {published data only}
    1. NCT04156971. Effects of omega-3 long-chain polyunsaturated fatty acids (N-3 LCPUFA) supplementation on body composition, biochemical profile, diet and physical activity of obese children. https://www.clinicaltrials.gov/study/NCT04156971 (first submitted 30 October 2019).
NCT04319419 {published data only}
    1. NCT04319419. Effectiveness of a supplement containing milk proteins, vitamins and minerals to reduce fat deposition, systemic inflammation and improve nutritional status in obese school-age children. https://www.clinicaltrials.gov/study/NCT04319419 (first submitted 28 February 2020).
NCT04430465 {published data only}
    1. NCT04430465. Effects of wholegrains on children's health (KORN). https://clinicaltrials.gov/show/NCT04430465 (first submitted 2020).
NCT04685057 {published data only}
    1. NCT04685057. Probiotic treatment for Prader-Willi syndrome. https://www.clinicaltrials.gov/study/NCT04685057 (first submitted 2 December 2020).
NCT04871360 {published data only}
    1. NCT04871360. Effect of oral L-citrulline supplementation on liver function and non-alcoholic fatty liver disease in adolescents with obesity. https://www.clinicaltrials.gov/study/NCT04871360 (first submitted 25 April 2021).
NCT04915638 {published data only}
    1. NCT04915638. Evaluation of nutritional status in Chimalhuacán children: anthropometric, biochemical, and molecular approaches. https://www.clinicaltrials.gov/study/NCT04915638 (first submitted 18 May 2021).
NCT05766657 {published data only}
    1. NCT05766657. Evaluation of an anti-inflammatory diet in autoimmune and metabolic diseases. https://clinicaltrials.gov/study/NCT05766657 (first submitted on 2022-12-02).

References to ongoing studies

Alisi 2014 {published data only}
    1. Alisi A, Bedogni G, Baviera G, Giorgio V, Porro E, Paris C, et al. Randomised clinical trial: the beneficial effects of VSL#3 in obese children with non-alcoholic steatohepatitis. Alimentary Pharmacology & Therapeutics 2014;39(11):1276-85. [DOI: 10.1111/apt.12758] - DOI - PMC - PubMed
Boque 2021 {published data only}
    1. Boque N, Tarro L, Rosi A, Torrell H, Saldana G, Luengo E, et al. Study protocol of a multicenter randomized controlled trial to tackle obesity through a Mediterranean diet vs. a traditional low-fat diet in adolescents: the MED4Youth study. International Journal of Environmental Research and Public Health 2021;18(9):4841. [DOI: 10.3390/ijerph18094841] - DOI - PMC - PubMed
ChiCTR1900026459 {published data only}
    1. ChiCTR1900026459. Construction of innovative platform for comprehensive management of simple obesity in children. https://www.chictr.org.cn/showprojEN.html?proj=22601 (first submitted 11 October 2019).
Deehan 2021 {published data only}
    1. Deehan EC, Colin-Ramirez E, Triador L, Madsen KL, Prado CM, Field CJ, et al. Efficacy of metformin and fermentable fiber combination therapy in adolescents with severe obesity and insulin resistance: study protocol for a double-blind randomized controlled trial. Trials 2021;22(1):148. [DOI: 10.1186/s13063-021-05060-8] - DOI - PMC - PubMed
Dello Russo 2022 {published data only}
    1. Dello Russo M, Russo P, Rufián-Henares JÁ, Hinojosa-Nogueira D, Pérez-Burillo S, De la Cueva SP, et al. The Stance4health project: evaluating a smart personalised nutrition service for gut microbiota modulation in normal- and overweight adults and children with obesity, gluten-related disorders or allergy/intolerance to cow's milk. Foods 2022;11(10):00. [DOI: 10.3390/foods11101480] - DOI - PMC - PubMed
Fatahi 2022 {published data only}
    1. Fatahi S, Sayyari AA, Salehi M, Safa M, Sohouli M, Shidfar F, et al. The effects of chitosan supplementation on anthropometric indicators of obesity, lipid and glycemic profles, and appetite-regulated hormones in adolescents with overweight or obesity: a randomized, double-blind clinical trial. BMC Pediatrics 2022;22(1):527. [DOI: 10.1186/s12887-022-03590-x] - DOI - PMC - PubMed
Herrera 2018 {published data only}
    1. Herrera L, Strong D, Knight R, Rhee K. Effect of probiotics and dietary changes on adiposity in children. Gastroenterology 2018;154(6):S200. [DOI: 10.1016/S0016-5085(18)31071-0] - DOI
IRCT20180805040703N2 {published data only}
    1. IRCT20180805040703N2. The effect of low-carbohydrate diet on food addiction and gut microflora. https://irct.behdasht.gov.ir/trial/61830 (first submitted 7 May 2022).
Joseph 2019 {published data only}
    1. Joseph N, Clayton JB, Hoops SL, Linhardt CA, Mohd Hashim A, Mohd Yusof BN, et al. Alteration of the gut microbiome in normal and overweight school children from Selangor with lactobacillus fermented milk administration. Evolutionary Bioinformatics 2020;16:1176934320965943. [DOI: 10.1177/1176934320965943] - DOI - PMC - PubMed
    1. Joseph N, Vasodavan K, Saipudin NA, Yusof BN, Kumar S, Nordin SA. Gut microbiota and short-chain fatty acids (SCFAs) profiles of normal and overweight school children in Selangor after probiotics administration. Journal of Functional Foods 2019;57:103-11. [DOI: 10.1016/j.jff.2019.03.042] - DOI
NCT04100109 {published data only}
    1. NCT04100109. Evaluating the metabolic effects of polylactose: a novel prebiotic. https://clinicaltrials.gov/study/NCT04100109 (first submitted 20 September 2019).
NCT04150991 {published data only}
    1. NCT04150991. Fiber intervention on gut microbiota in children with Prader-Willi syndrome. https://clinicaltrials.gov/study/NCT04150991 (first submitted 15 October 2019).
NCT05540678 {published data only}
    1. NCT05540678. The Fibregum study - changing the course of obesity in children. https://clinicaltrials.gov/study/NCT05540678 (first submitted 5 September 2022).
NCT05623007 {published data only}
    1. NCT05623007. Dietary modulation of gut microbiota in overweight/obese adolescents and COVID-19 infection (DIVINE). https://clinicaltrials.gov/study/NCT05623007 (first submitted 31 October 2022).
NCT06309121 {published data only}
    1. NCT06309121. Effects of the postbiotic blend ABB C3 on adiposity and glucose metabolism in children and adolescents (Postob). https://clinicaltrials.gov/study/NCT06309121 (first submitted 27 February 2024).
Solito 2021 {published data only}
    1. Solito A, Cionci NB, Calgaro M, Caputo M, Vannini L, Hasballa I, et al. Supplementation with Bifidobacterium breve BR03 and B632 strains improved insulin sensitivity in children and adolescents with obesity in a cross-over, randomized double-blind placebo-controlled trial. Clinical Nutrition (Edinburgh, Scotland) 2021;40(7):4585-94. [DOI: 10.1016/j.clnu.2021.06.002] - DOI - PubMed
    1. Solito A, Ricotti R, Archero F, Aloisio I, Giglione E, Cionci NB, et al. Efficacy of the treatment with Bifidobacterium breve B632 and Bifidobacterium breve BR03 on endocrine response to the oral glucose tolerance test in pediatric obesity: a cross-over double blind randomized controlled trial. High Blood Pressure & Cardiovascular Prevention 2018;25(2):226-7. [DOI: 10.1007/s40292-018-0249-0] - DOI

Additional references

Abedi 2014
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