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RECRUITING
NCT07148583
NA

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

Sponsor: Haiphong University of Medicine and Pharmacy

View on ClinicalTrials.gov

Summary

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.

Official title: Evaluation of the Efficacy and Safety of the Multistrain Probiotic "BioAmicus Complete" in Improving Gastrointestinal Symptoms in Children Aged 0-24 Months: A Randomized, Open-Label, Parallel-Group, Controlled Trial

Key Details

Gender

All

Age Range

0 Days - 24 Months

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2025-09-05

Completion Date

2026-05-30

Last Updated

2026-01-29

Healthy Volunteers

No

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.

Locations (1)

Clinical Trial and Bioequivalence Center

Haiphong, Hai Phong, Vietnam