NCT07148583

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Haiphong University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 0 Days – 24 Months
• Healthy volunteers: Not accepted

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.

Detailed description

caregiver burden and health care visits. Modulating the developing gut microbiome with probiotics may alleviate these symptoms. BioAmicus Complete is a multistrain probiotic designed to support a healthy intestinal microbiota; systematic clinical evaluation is warranted to determine its efficacy and safety in infants. Objectives: Primary: Determine whether BioAmicus Complete improves overall gastrointestinal symptoms versus usual care, measured by change in IGSQ total score between baseline and study end. Exploratory (microbiome): Characterize changes in stool microbiome composition and diversity across the study period. Secondary: Compare groups on symptom domain scores (e.g., colic, regurgitation, stooling patterns), caregiver burden/quality of life, health care utilization and antibiotic exposure, growth parameters, and safety outcomes (adverse events, serious adverse events, and product-related events). Significance: Findings will inform whether BioAmicus Complete can be recommended as an adjunct to routine care for infant functional gastrointestinal symptoms and will provide preliminary insights into microbiome changes associated with symptom improvement.

Conditions

• Infantile Colic
• Gastroesophageal Reflux (GER)
• Functional Constipation
• Functional Diarrhea
• Dysbiosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-05
• Primary completion: 2026-04-30
• Completion: 2026-05-30
• First posted: 2025-08-29
• Last updated: 2026-01-29

Locations

1 site across 1 country: Vietnam