Probiotics and diarrhoea morbidity among infants in Tanzania: secondary analysis of a randomised clinical trial
9 affiliations
- 1Research Group for Child and Adolescent Health,Department of Clinical Medicine, Faculty of Health Sciences, UiT-The Arctic University of Norway, Tromsø, Norway
- 2Department of Paediatrics, Haydom Lutheran Hospital, Mbulu, Manyara, Tanzania
- 3Haydom Global Health Research Centre, Haydom Lutheran Hospital, Mbulu, Manyara, Tanzania
- 4Host-Microbe Interaction Research Group, Department of Medical Biology, Faculty of Health Sciences, UiT-The Arctic University of Norway, Tromsø, Norway
- 5Department of Clinical Science, University of Bergen, Bergen, Norway
- 6National Centre for Tropical Infectious Diseases, Haukeland University Hospital, Bergen, Norway
- 7Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Liverpool, UK
- 8Department of Medical Microbiology, Stavanger University Hospital, Stavanger, Norway
- 9Department of Paediatrics and Adolescent Medicine, University Hospital of North Norway, Tromsø, Norway
Abstract
Introduction Diarrhoea causes annually more than 444 000 deaths in children globally, the majority in infants in low-income countries. The gut microbiota is a key determinant in resilience against enteric infections. We evaluated the effects of Bifidobacterium-based probiotic supplementation on diarrhoea morbidity among infants in Tanzania and explored associations between the gut microbiota composition at 6 weeks of age and later diarrhoeal risk.Methods Secondary analysis of a double-blind, placebo-controlled randomised trial including infants in rural Tanzania between 1 February 2022 and 4 January 2023. 2000 participants were enrolled and randomly assigned to probiotics (n=1000) or placebo (n=1000), starting within the first 3 days of life and administered daily by caregivers in the first 4 weeks of life. Stool samples for gut microbiota analyses were collected 6 weeks after birth. The primary outcome was rate and duration of diarrhoea until 6 months of age. Secondary outcomes were associations between gut microbiota composition at 6 weeks of age and subsequent risk of diarrhoea.Results Among 1945 infants with 6-month follow-up data, 126 infants developed diarrhoea, with no significant difference in rates between probiotic (53/970, 5.5%) or placebo (73/975, 7.5%) groups, p=0.070. Total days with diarrhoea were lower in the probiotic group (638 days) than in the placebo group (1057 days), p=0.048. Persistent diarrhoea (>14 days) occurred less frequently in the probiotic group (13%) versus placebo group (29%), p=0.038. A metagenomic comparison of 100 diarrhoea cases and 235 non-diarrhoea matched controls revealed significantly different taxonomic profiles between infants who later developed diarrhoea and those who did not. Enteric pathobionts were enriched, and lactic acid-producing commensals depleted among diarrhoea cases.Conclusion Early-life probiotic supplementation was associated with lower total days of diarrhoea and a lower occurrence of persistent diarrhoea, but not with significantly lower rates of diarrhoea between probiotic and placebo groups. Differences in early gut microbiota preceding illness suggest that the microbial composition may impact susceptibility to diarrhoeal disease.Trial registration ClinicalTrials.gov ID: NCT04172012.
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BibTeX
@article{justine2026probiotics,
title = {{Probiotics and diarrhoea morbidity among infants in Tanzania: secondary analysis of a randomised clinical trial}},
author = {Museveni Justine and Ahmed Bargheet and Bjørn Blomberg and Sabrina John Moyo and Joshua Gideon Gidabayda and Iren Høyland Löhr and Saning’o Lukumay and Veronika Kuchařová Pettersen and Nina Langeland and Claus Klingenberg},
journal = {BMJ Paediatrics Open},
year = {2026},
month = oct,
doi = {10.1136/bmjpo-2026-005152},
url = {https://doi.org/10.1136/bmjpo-2026-005152},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Probiotics and diarrhoea morbidity among infants in Tanzania: secondary analysis of a randomised clinical trial
AU - Museveni Justine
AU - Ahmed Bargheet
AU - Bjørn Blomberg
AU - Sabrina John Moyo
AU - Joshua Gideon Gidabayda
AU - Iren Høyland Löhr
AU - Saning’o Lukumay
AU - Veronika Kuchařová Pettersen
AU - Nina Langeland
AU - Claus Klingenberg
PY - 2026
DA - 2026/10/31
JO - BMJ Paediatrics Open
DO - 10.1136/bmjpo-2026-005152
UR - https://doi.org/10.1136/bmjpo-2026-005152
AB - Introduction Diarrhoea causes annually more than 444 000 deaths in children globally, the majority in infants in low-income countries. The gut microbiota is a key determinant in resilience against enteric infections. We evaluated the effects of Bifidobacterium-based probiotic supplementation on diarrhoea morbidity among infants in Tanzania and explored associations between the gut microbiota composition at 6 weeks of age and later diarrhoeal risk.Methods Secondary analysis of a double-blind, placebo-controlled randomised trial including infants in rural Tanzania between 1 February 2022 and 4 January 2023. 2000 participants were enrolled and randomly assigned to probiotics (n=1000) or placebo (n=1000), starting within the first 3 days of life and administered daily by caregivers in the first 4 weeks of life. Stool samples for gut microbiota analyses were collected 6 weeks after birth. The primary outcome was rate and duration of diarrhoea until 6 months of age. Secondary outcomes were associations between gut microbiota composition at 6 weeks of age and subsequent risk of diarrhoea.Results Among 1945 infants with 6-month follow-up data, 126 infants developed diarrhoea, with no significant difference in rates between probiotic (53/970, 5.5%) or placebo (73/975, 7.5%) groups, p=0.070. Total days with diarrhoea were lower in the probiotic group (638 days) than in the placebo group (1057 days), p=0.048. Persistent diarrhoea (>14 days) occurred less frequently in the probiotic group (13%) versus placebo group (29%), p=0.038. A metagenomic comparison of 100 diarrhoea cases and 235 non-diarrhoea matched controls revealed significantly different taxonomic profiles between infants who later developed diarrhoea and those who did not. Enteric pathobionts were enriched, and lactic acid-producing commensals depleted among diarrhoea cases.Conclusion Early-life probiotic supplementation was associated with lower total days of diarrhoea and a lower occurrence of persistent diarrhoea, but not with significantly lower rates of diarrhoea between probiotic and placebo groups. Differences in early gut microbiota preceding illness suggest that the microbial composition may impact susceptibility to diarrhoeal disease.Trial registration ClinicalTrials.gov ID: NCT04172012.
SN - 2399-9772
ER -