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

NANot yet recruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

September 5, 2025

Primary Completion Date

April 30, 2026

Study Completion Date

May 30, 2026

Conditions
Infantile ColicGastroesophageal Reflux (GER)Functional ConstipationFunctional DiarrheaDysbiosis
Interventions
DIETARY_SUPPLEMENT

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.

OTHER

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.

Trial Locations (1)

180000

Clinical Trial and Bioequivalence Center, Haiphong

All Listed Sponsors
lead

Haiphong University of Medicine and Pharmacy

OTHER

NCT07148583 - BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months | Biotech Hunter | Biotech Hunter