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

Conditions

• Functional Gastrointestinal Disorders (FGIDs)
• Weight Loss

Interventions

OTHER

RO water

RO water (Aquafina, PepsiCo) produced under ISO 9001:2015 and ISO 22000:2018 standards. The RO water ampoules are produced using a similar process as the LIVESPO PREG-MOM/CONSY but contain 5 mL of high-quality RO water from Aquafina.

COMBINATION_PRODUCT

LiveSpo PREG-MOM

LiveSpo PREG-MOM has a registration number 7695/2020/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.

COMBINATION_PRODUCT

LiveSpo CONSY

LiveSpo CONSY has a registration number 4165/2020/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.

Sponsors & Collaborators

• Hanoi Obstetrics and Gynecology Hospital

  collaborator OTHER

• Anabio R&D

  lead INDUSTRY

Principal Investigators

• Hung T Mai, PhD · Hanoi Obstetrics and Gynecology Hospital

• Chuong C Nguyen · Hanoi Obstetrics and Gynecology Hospital

• Anh TV Nguyen, Assoc.Prof.PhD · Anabio R&D

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

0 Days

Max Age

1 Day

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-01-07

Primary Completion

2026-09-07

Completion

2027-01-07

Countries

• Vietnam

Study Locations