Status:
NOT_YET_RECRUITING
BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
Lead Sponsor:
Haiphong University of Medicine and Pharmacy
Conditions:
Infantile Colic
Gastroesophageal Reflux (GER)
Eligibility:
All Genders
Up to 24 years
Phase:
NA
Brief 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 ...
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 heal...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07148583
Start Date
September 5 2025
End Date
May 30 2026
Last Update
September 8 2025
Active Locations (1)
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1
Clinical Trial and Bioequivalence Center
Haiphong, Hai Phong, Vietnam, 180000