BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months (CTBE2503)

Haiphong University of Medicine and Pharmacy

Status: Begins enrollment this month

Conditions: Functional Constipation; Infantile Colic; Dysbiosis; Gastroesophageal Reflux (GER); Functional Diarrhea

Treatments: Other: Usual Care (No Probiotic); Dietary Supplement: BioAmicus Complete

Study type: Interventional

Funder types: Other

Identifiers

NCT07148583

CTBE.25.03

Protocol No.: CTBE.25.03 (Other Identifier)

Details and patient eligibility

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.

Full 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 healthy intestinal microbiota; systematic clinical evaluation is warranted to determine its efficacy and safety in infants.

Objectives:

Primary: Determine whether BioAmicus Complete improves overall gastrointestinal symptoms versus usual care, measured by change in IGSQ total score between baseline and study end.

Exploratory (microbiome): Characterize changes in stool microbiome composition and diversity across the study period.

Secondary: Compare groups on symptom domain scores (e.g., colic, regurgitation, stooling patterns), caregiver burden/quality of life, health care utilization and antibiotic exposure, growth parameters, and safety outcomes (adverse events, serious adverse events, and product-related events).

Significance: Findings will inform whether BioAmicus Complete can be recommended as an adjunct to routine care for infant functional gastrointestinal symptoms and will provide preliminary insights into microbiome changes associated with symptom improvement.

Enrollment: 110 estimated patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

BioAmicus Complete + Usual Care

Experimental group

Description:

Participants receive BioAmicus Complete (multistrain probiotic) oral drops in addition to usual care for infant functional GI symptoms. Product is administered by caregivers per protocol/label for 42 days; adherence is recorded. No other probiotic products are permitted during the study. Concomitant medications and routine management are allowed at the investigator's discretion.

Treatment:

Dietary Supplement: BioAmicus Complete

Other: Usual Care (No Probiotic)

Usual Care Alone

Active Comparator group

Description:

Participants receive standard clinical management per local practice for infant functional gastrointestinal symptoms. No probiotic supplementation is provided (participants are asked to avoid other probiotic products during the study). Concomitant medications and supportive care may be used as clinically indicated at the investigator's discretion.

Treatment:

Other: Usual Care (No Probiotic)