Actively Recruiting
BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
Led by Haiphong University of Medicine and Pharmacy · Updated on 2026-01-29
110
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 0-24 months at enrollment
- Infant has clinician-assessed functional gastrointestinal symptoms such as colic, regurgitation, constipation, or loose stools suitable for study participation
- Parent or legal guardian provides written informed consent and agrees to comply with study procedures including questionnaires, diaries, and sample collection
- Caregivers agree to avoid other probiotic products during the study period unless directed by the study team
You will not qualify if you...
- Major congenital gastrointestinal anomalies or chronic gastrointestinal diseases requiring ongoing prescription therapy such as Hirschsprung disease, inflammatory bowel disease, or short-bowel syndrome
- Clinically unstable condition or severe/critical illness interfering with participation or safety as judged by 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
- Use of systemic antibiotics or probiotic supplements within 14 days prior to baseline
- Participation in another interventional clinical trial within 30 days prior to enrollment or during the study
- Any condition that would make the participant unsuitable for the study or confound outcome assessments as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clinical Trial and Bioequivalence Center
Haiphong, Hai Phong, Vietnam, 180000
Actively Recruiting
Research Team
N
Nguyen Thi Thu Phuong, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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