110
Participants
Start Date
September 5, 2025
Primary Completion Date
April 30, 2026
Study Completion Date
May 30, 2026
BioAmicus Complete
Oral liquid probiotic (multistrain) administered by caregivers per protocol/label for 42 days to infants with functional GI symptoms. Given as drops by mouth; dosing and administration instructions per protocol. No other probiotic products allowed during the study. Concomitant medications and routine management may be used as clinically indicated. Adherence is recorded; lot/batch number captured.
Usual Care (No Probiotic)
Standard clinical management for infant functional gastrointestinal symptoms per local practice. No probiotic supplementation is provided during the study period. Participants follow the same visit and assessment schedule as the intervention arm. Concomitant medications and supportive care may be used as clinically indicated.
Clinical Trial and Bioequivalence Center, Haiphong
Haiphong University of Medicine and Pharmacy
OTHER