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
Haiphong University of Medicine and Pharmacy
110 participants
Sep 5, 2025
INTERVENTIONAL
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.
Eligibility
Inclusion Criteria4
- Age 0-24 months at enrollment.
- Infant has clinician-assessed functional gastrointestinal symptoms (e.g., colic/irritability, regurgitation, constipation, loose stools), judged suitable for study participation.
- Parent or legal guardian provides written informed consent and agrees to comply with study procedures (questionnaires/diaries and sample collection, if applicable).
- Caregivers agree to avoid other probiotic products during the study period, except as directed by the study team.
Exclusion Criteria7
- Major congenital gastrointestinal anomalies or known chronic gastrointestinal diseases requiring ongoing prescription therapy (e.g., Hirschsprung disease, inflammatory bowel disease, short-bowel syndrome).
- Clinically unstable condition or severe/critical illness that could interfere with participation or safety in the opinion of the investigator.
- Known or suspected primary or secondary immunodeficiency, or current immunosuppressive therapy.
- History of severe allergy or hypersensitivity to components of the investigational product.
- Recent use of systemic antibiotics within 14 days prior to baseline, or use of probiotic supplements within 14 days prior to baseline (per protocol).
- Participation in another interventional clinical trial within 30 days prior to enrollment or during the study.
- Any condition that, in the investigator's judgment, would make the participant unsuitable for the study or confound outcome assessments.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07148583