Effects of Multi-strain Bacillus Spore Probiotics on Growth, Digestive Function, and Gut Microbiota in Cesarean-Delivered Neonates

Summary

Infants born by cesarean section commonly show early weight loss and slower recovery of birth weight, together with characteristic patterns of gut microbiota dysbiosis marked by reduced Bifidobacterium and Bacteroides and increased Proteobacteria. This early microbial alteration has been associated with functional gastrointestinal disorders (FGIDs), including colic, regurgitation, and changes in stool frequency and consistency, which may in turn affect early growth and overall gastrointestinal functioning. Probiotic supplementation is considered a safe and feasible strategy to support microbial restoration and improve digestive function during the first months of life. In this study, researchers propose that daily supplementation with multi-strain Bacillus spore probiotics may help support healthy early growth, reduce functional gastrointestinal symptoms, and promote a more balanced gut microbiota in cesarean-delivered infants. The objective of this study is to evaluate the safety and efficacy of two oral probiotic formulations, LiveSpo PREG-MOM and LiveSpo CONSY, containing multi-strain B. subtilis ANA46, B. clausii ANA39, and B. coagulans ANA40 at respective 3 and 4 billion colony-forming units (CFU)/5 mL ampoule, administered 1 ampoule daily, during the first 90 days of life. The study examines effects on growth, digestive symptoms, immune markers, and microbial composition. Study Design: This randomized, blind, controlled clinical trial will enroll 180 healthy full-term cesarean-born infants at Hanoi Obstetrics and Gynecology Hospital. Intervention Description: Participants will be randomly assigned to three groups (n = 60 each). All groups will receive one 5-mL ampoule daily for 90 days: LiveSpo PREG-MOM, LiveSpo CONSY, or placebo. Stool samples will be collected at several follow-up time points to assess digestive health and microbial development. All products will be provided in blinded and coded packaging to maintain objectivity. Study Duration: 12 months

Timeline

Start

2026-01-07

Primary completion

2026-09-07

Completion

2027-01-07

Publications

• Background Long G, Hu Y, Tao E, Chen B, Shu X, Zheng W, Jiang M. The Influence of Cesarean Section on the Composition and Development of Gut Microbiota During the First 3 Months of Life. Front Microbiol. 2021 Aug 18;12:691312. doi: 10.3389/fmicb.2021.691312. eCollection 2021.
• Background Kelly NM, Keane JV, Gallimore RB, Bick D, Tribe RM. Neonatal weight loss and gain patterns in caesarean section born infants: integrative systematic review. Matern Child Nutr. 2020 Apr;16(2):e12914. doi: 10.1111/mcn.12914. Epub 2019 Nov 27.
• Background Ianiro G, Rizzatti G, Plomer M, Lopetuso L, Scaldaferri F, Franceschi F, Cammarota G, Gasbarrini A. Bacillus clausii for the Treatment of Acute Diarrhea in Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients. 2018 Aug 12;10(8):1074. doi: 10.3390/nu10081074.
• Background Gong Y, Zhong H, Wang J, Wang X, Huang L, Zou Y, Qin H, Yang R. Effect of Probiotic Supplementation on the Gut Microbiota Composition of Infants Delivered by Cesarean Section: An Exploratory, Randomized, Open-label, Parallel-controlled Trial. Curr Microbiol. 2023 Sep 15;80(11):341. doi: 10.1007/s00284-023-03444-4.
• Background Delfino E, Peano L, Wetzl RG, Gianni ML, Netto R, Consales A, Bettinelli ME, Morniroli D, Vielmi F, Mosca F, Montagnani L. Newborn Weight Loss as a Predictor of Persistence of Exclusive Breastfeeding up to 6 Months. Front Pediatr. 2022 Apr 7;10:871595. doi: 10.3389/fped.2022.871595. eCollection 2022.
• Background Colom J, Freitas D, Simon A, Brodkorb A, Buckley M, Deaton J, Winger AM. Presence and Germination of the Probiotic Bacillus subtilis DE111(R) in the Human Small Intestinal Tract: A Randomized, Crossover, Double-Blind, and Placebo-Controlled Study. Front Microbiol. 2021 Aug 2;12:715863. doi: 10.3389/fmicb.2021.715863. eCollection 2021.
• Background Bernardeau M, Lehtinen MJ, Forssten SD, Nurminen P. Importance of the gastrointestinal life cycle of Bacillus for probiotic functionality. J Food Sci Technol. 2017 Jul;54(8):2570-2584. doi: 10.1007/s13197-017-2688-3. Epub 2017 May 23.

Drugs

Indications

No indication recorded.