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

This study will see if the multistrain probiotic BioAmicus Complete can help reduce caregiver‑reported tummy symptoms in infants aged 0–24 months.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 0 Days to 24 Months
• Sex: All
• Sponsor: Haiphong University of Medicine and Pharmacy (other)
• Locations: 1 site (Haiphong, Hai Phong)
• Trial ID: NCT07148583 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are infants aged 0–24 months with clinician‑assessed functional GI symptoms whose caregivers can provide consent, complete questionnaires/diaries, collect stool samples as requested, and avoid other probiotic products during the study.

Not a fit: Infants with major congenital gastrointestinal anomalies, chronic GI diseases requiring ongoing prescription therapy, known immunodeficiency or current immunosuppression, or clinically unstable severe illness are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this could offer a safe, easy‑to‑use probiotic option to reduce infant gastrointestinal symptoms and lower caregiver burden.

How similar studies have performed: Some single‑strain probiotics have shown benefits for specific infant symptoms like colic or regurgitation in prior trials, but results are mixed and multistrain formulations such as BioAmicus Complete have not been extensively tested.

Eligibility criteria

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 this trial is running

Haiphong, Hai Phong

• Clinical Trial and Bioequivalence Center — Haiphong, Hai Phong, Vietnam (RECRUITING)

Study contacts

• Study coordinator: Nguyen Thi Thu Phuong, MD, PhD

Conditions: Infantile Colic, Gastroesophageal Reflux, Functional Constipation, Functional Diarrhea, Dysbiosis, BioAmicus Complete, probiotic, multistrain probiotic