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

Eligibility

Inclusion Criteria:

* Healthy term neonates delivered by cesarean section.
* Infants were born at term, ranging from 38 to 40 weeks' gestation.
* Birth weight appropriate for gestational age (AGA), defined as between the 10th and 90th percentiles for gestational age (≥P10 and ≤P90).
* The infant's parent(s) or legal guardian(s) provide written informed consent and agree to comply with study procedures.

Exclusion Criteria:

For the neonate:

* Multiple births (twins, triplets, etc.)
* Birth weight outside the appropriate-for-gestational-age range: small for gestational age (SGA, \< P10) or large for gestational age (LGA, \> P90).
* Major congenital abnormalities affecting the hematologic, hepatobiliary, cardiovascular, renal/urinary, or gastrointestinal systems; severe inborn errors of metabolism; or suspected primary immunodeficiency.
* Prior exposure to systemic or enteral antibiotics (oral, IV, or IM) before the baseline assessment.
* Known allergy or intolerance to any component of the investigational product.
* Concurrent participation in another interventional clinical trial.
* The investigators judge the neonate to be unsuitable for participation.
* Parent(s) or legal guardian(s) who do not comply with study requirements or refuse to sign the informed consent.

For the mother:

* Mother diagnosed with a serious or unstable medical condition involving the hepatobiliary, renal/urinary, cardiovascular, respiratory, endocrine/metabolic, or psychiatric systems.
* Mother who intends to use, or is prescribed, any other probiotic/prebiotic product for herself or the infant during the study period.

Conditions2

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