Use of Probiotics to Reduce Infections, Death and ESBL Colonisation

Summary

This study examines the effect of oral probiotic treatment to newborns on preventing hospitalizations, death and colonization with Extended-spectrum beta-lactamase-producing Gram negative bacteria. Half of the babies will receive 4 weeks treatment with an oral mixture of the probiotic Labinic (R) while the other half will receive a placebo mixture.

Timeline

Start

2022-02-01

Primary completion

2023-07-10

Completion

2023-09-19

Publications

• Background Panigrahi P, Parida S, Nanda NC, Satpathy R, Pradhan L, Chandel DS, Baccaglini L, Mohapatra A, Mohapatra SS, Misra PR, Chaudhry R, Chen HH, Johnson JA, Morris JG, Paneth N, Gewolb IH. A randomized synbiotic trial to prevent sepsis among infants in rural India. Nature. 2017 Aug 24;548(7668):407-412. doi: 10.1038/nature23480. Epub 2017 Aug 16.
• Background Esaiassen E, Hjerde E, Cavanagh JP, Pedersen T, Andresen JH, Rettedal SI, Stoen R, Nakstad B, Willassen NP, Klingenberg C. Effects of Probiotic Supplementation on the Gut Microbiota and Antibiotic Resistome Development in Preterm Infants. Front Pediatr. 2018 Nov 16;6:347. doi: 10.3389/fped.2018.00347. eCollection 2018.
• Background Tellevik MG, Blomberg B, Kommedal O, Maselle SY, Langeland N, Moyo SJ. High Prevalence of Faecal Carriage of ESBL-Producing Enterobacteriaceae among Children in Dar es Salaam, Tanzania. PLoS One. 2016 Dec 9;11(12):e0168024. doi: 10.1371/journal.pone.0168024. eCollection 2016.
• Moyo SJ, Justine M, Blomberg B, Lohr IH, Gideon J, Mdoe P, Mduma E, Manyahi J, Pettersen VK, Paschal J, Syre H, Bukhay R, Klingenberg C, Langeland N. Navigating the trials of a trial: lessons from ProRIDE on recruitment, retention, and follow-up in rural Africa. Trials. 2026 Jan 15;27(1):125. doi: 10.1186/s13063-026-09447-3.
• Klingenberg C, Justine M, Moyo SJ, Lohr IH, Gideon J, Mdoe P, Mduma E, Manyahi J, Bargheet A, Pettersen VK, Paschal J, Syre H, Bernhoff E, Bukhay R, Blomberg B, Langeland N. Home administration of a multistrain probiotic once per day for 4 weeks to newborn infants in Tanzania (ProRIDE): a double-blind, placebo-controlled randomised trial. Lancet Glob Health. 2025 Jun;13(6):e1082-e1090. doi: 10.1016/S2214-109X(25)00064-6.
• Kuwelker K, Langeland N, Lohr IH, Gidion J, Manyahi J, Moyo SJ, Blomberg B, Klingenberg C. Use of probiotics to reduce infections and death and prevent colonization with extended-spectrum beta-lactamase (ESBL)-producing bacteria among newborn infants in Tanzania (ProRIDE Trial): study protocol for a randomized controlled clinical trial. Trials. 2021 Apr 29;22(1):312. doi: 10.1186/s13063-021-05251-3.

Drugs

Indications