Multi-strain Bacillus probiotic for cesarean-delivered newborns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls healthy term neonates delivered by cesarean section to receive a daily multi-strain Bacillus spore probiotic formulation. The aim is to see if probiotic supplementation can support early weight gain and reduce functional gastrointestinal symptoms by promoting a balanced gut microbiota, including key beneficial bacteria. The approach leverages spore-forming Bacillus strains known for stability and gut passage, with safety monitoring throughout the neonatal period. Participants receive the probiotic alongside standard care, with assessments focused on growth trajectories, digestive function, and microbiota composition. The study is conducted at Hanoi Obstetrics and Gynecology Hospital with Anabio R&D as lead sponsor and collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hanoi Obstetrics and Gynecology Hospital
  Hanoi, Vietnam Recruiting

Study contacts

• Principal investigator: Hung T Mai, PhD — Hanoi Obstetrics and Gynecology Hospital
• Study coordinator: Hung T Mai, PhD
• Email: bacsymaitronghung@gmail.com
• Phone: (+84) 988.855.888

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.