BioAmicus Complete for infants with colic, reflux, constipation, or loose stools (0–24 months)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study randomizes infants with clinician‑assessed functional gastrointestinal symptoms to receive BioAmicus Complete or usual care and follows them over the study period to measure change in symptoms. The primary outcome is the change in Infant Gastrointestinal Symptom Questionnaire (IGSQ) total score from baseline to end of study. Secondary outcomes include symptom domains (colic/regurgitation, stool frequency and consistency), caregiver quality of life, growth, health care use and antibiotic exposure, and safety monitoring for adverse events. Stool samples will be collected for exploratory analysis of microbiome composition and diversity to explore biological changes associated with symptom changes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Clinical Trial and Bioequivalence Center
  Haiphong, Hai Phong, Vietnam Recruiting

Study contacts

• Study coordinator: Nguyen Thi Thu Phuong, MD, PhD
• Email: nttphuong@hpmu.edu.vn
• Phone: +84936685007

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.