Study of BioAmicus Complete Probiotic Drops to Improve Gastrointestinal Symptoms in Infants up to 24 Months

What this Trial Is About

Infants commonly experience functional gastrointestinal symptoms such as colic, excessive gas, regurgitation, constipation, or loose stools, which can distress families and may be linked to an imbalance in the gut microbiome. This research evaluates whether the multistrain probiotic BioAmicus Complete can improve these caregiver-reported symptoms in infants aged 0 to 24 months and assesses its safety in this group. The study also explores changes in stool microbiome composition and diversity over time. Participants are randomly assigned to one of two groups one group receives BioAmicus Complete oral probiotic drops along with usual care for 42 days, while the other group receives standard clinical management without probiotic supplementation. Caregivers administer the probiotic drops per protocol, and use of other probiotic products is avoided during the study. Concomitant medications and routine care are allowed at the investigators discretion. Adherence to the probiotic regimen is recorded. During the study, caregivers complete questionnaires and diaries to report gastrointestinal symptoms and quality of life. Researchers monitor growth parameters like weight and length, track health care use and antibiotic exposure, and collect stool samples for microbiome analysis. Safety is assessed by recording adverse events. The primary measure is the change in Infant Gastrointestinal Symptom Questionnaire IGSQ total score from baseline to day 42. Secondary measures include stool frequency and consistency, symptom domains, and overall safety outcomes. The study runs until May 2026.

BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months