Gut microbiome-based interventions for the management of obesity in children and adolescents aged up to 19 years
- PMID: 40637175
- PMCID: PMC12243456
- DOI: 10.1002/14651858.CD015875
Gut microbiome-based interventions for the management of obesity in children and adolescents aged up to 19 years
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.
Copyright © 2025 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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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NCT02168660 {published data only}
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- 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}
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- NCT02948647. Healthy eating through reduction of excess sugar. https://clinicaltrials.gov/study/NCT02948647.
NCT03115385 {published data only}
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- NCT03115385. Probiotics and the gut microbiome in obese hispanic youth. https://ClinicalTrials.gov/show/NCT03115385 (first submitted: 29 March 2017).
NCT03358524 {published data only}
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- 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}
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- 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}
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- NCT03629119. Psylliumrx dietary fiber study. https://www.clinicaltrials.gov/study/NCT03629119 (first submitted 9 August 2018).
NCT03870984 {published data only}
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- NCT03870984. Efficacy of nuts in obese children. https://www.clinicaltrials.gov/study/NCT03870984 (first submitted 6 March 2019).
NCT04112251 {published data only}
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- 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}
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- 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}
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- 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}
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- NCT04770311. Childhood obesity microbiome study (CHOICE). https://www.clinicaltrials.gov/study/NCT04770311 (first submitted 23 February 2021).
NCT04783116 {published data only}
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- 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}
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- 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}
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- 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}
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- 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}
RBR‐5h255qr {published data only}
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- 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}
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- 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}
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- NCT02948647. Healthy eating through reduction of excess sugar (HEROES). https://www.clinicaltrials.gov/study/NCT02948647 (first submitted 25 October 2016).
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- 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}
SLCTR/2016/021 {published data only}
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- 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}
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- 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}
Videhult 2015a {published data only}
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- 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}
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- 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).
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- 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}
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- 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}
Wu 2017 {published data only}
Xie 2021 {published data only}
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- 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).
Youssef 2020 {published data only}
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- 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}
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- NCT02280772. Effect of glucomannan supplementation on body weight in overweight and obese children. https://www.clinicaltrials.gov/study/NCT02280772 (first submitted 29 October 2014).
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NCT04150991 {published data only}
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NCT05540678 {published data only}
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