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

Infants often experience functional gastrointestinal symptoms (e.g., colic, excessive gas, regurgitation, constipation, or loose stools) that distress families and may reflect an imbalance of the gut microbiome. This study evaluates whether the multistrain probiotic BioAmicus Complete can improve caregiver-reported gastrointestinal symptoms in infants 0-24 months and is safe for use in this population. The primary assessment is the change in the Infant Gastrointestinal Symptom Questionnaire (IGSQ) total score from the start to the end of the study period. Secondary assessments include symptom domains (colic/regurgitation, stool frequency and consistency), caregiver quality of life, growth parameters (weight and length), health care utilization and antibiotic exposure, and overall safety/tolerability (adverse events and serious adverse events). Stool samples will be analyzed to explore changes in the gut microbiome.

NCT Number	NCT07148583
Lead Sponsor	Haiphong University of Medicine and Pharmacy
Conditions	Infantile Colic, Gastroesophageal Reflux (GER), Functional Constipation, Functional Diarrhea, Dysbiosis
Enrollment	110 participants
Start Date	2025-09-05
Primary Completion	2026-04-30 (estimated)
Study Completion	2026-05-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-29