Actively Recruiting
Evaluation of the Efficacy and Safety of the Multistrain Probiotic BioAmicus Complete in Improving Gastrointestinal Symptoms in Infants Aged 0 to 24 Months in a Randomized, Open-Label, Controlled Trial
Led by Haiphong University of Medicine and Pharmacy · Updated on 2026-01-29
110
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Infants commonly experience functional gastrointestinal symptoms such as colic, excessive gas, regurgitation, constipation, or loose stools, which can distress families and may be linked to an imbalance in the gut microbiome. This research evaluates whether the multistrain probiotic BioAmicus Complete can improve these caregiver-reported symptoms in infants aged 0 to 24 months and assesses its safety in this group. The study also explores changes in stool microbiome composition and diversity over time. Participants are randomly assigned to one of two groups: one group receives BioAmicus Complete oral probiotic drops along with usual care for 42 days, while the other group receives standard clinical management without probiotic supplementation. Caregivers administer the probiotic drops per protocol, and use of other probiotic products is avoided during the study. Concomitant medications and routine care are allowed at the investigator's discretion. Adherence to the probiotic regimen is recorded. During the study, caregivers complete questionnaires and diaries to report gastrointestinal symptoms and quality of life. Researchers monitor growth parameters like weight and length, track health care use and antibiotic exposure, and collect stool samples for microbiome analysis. Safety is assessed by recording adverse events. The primary measure is the change in Infant Gastrointestinal Symptom Questionnaire (IGSQ) total score from baseline to day 42. Secondary measures include stool frequency and consistency, symptom domains, and overall safety outcomes. The study runs until May 2026.
CONDITIONS
Brief Title
BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant aged 0 to 24 months at enrollment
- Clinician-assessed functional gastrointestinal symptoms such as colic, regurgitation, constipation, or loose stools
- Parent or legal guardian provides written informed consent and agrees to study procedures
- 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 needing ongoing prescription therapy
- Clinically unstable condition or severe/critical illness interfering with participation or safety
- Known or suspected immunodeficiency or current immunosuppressive therapy
- History of severe allergy or hypersensitivity to the investigational product components
- 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 judged by the investigator to make participation unsuitable or confound outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 42 days
Participants receive either BioAmicus Complete probiotic oral drops plus usual care or usual care alone for infant functional gastrointestinal symptoms. The probiotic is administered by caregivers as per protocol for 42 days. Participants avoid other probiotic products during this period.
Visits occur at baseline and Day 42 for assessments
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
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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