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

RecruitingNAAges 0 Days - 1 DayAllAnabio R&D
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (โ‰ฅP10 and โ‰คP90). * 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.
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What it tests

  • RO water
  • LiveSpo PREG-MOM
  • LiveSpo CONSY
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Where

1 site
Hanoi Obstetrics and Gynecology Hospital
Hanoi, Vietnam
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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