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

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 forstudy participation.

• Parent or legal guardian provides written informed consent and agrees to comply withstudy procedures (questionnaires/diaries and sample collection, if applicable).

• Caregivers agree to avoid other probiotic products during the study period, exceptas directed by the study team.

Exclusion Criteria:

• Major congenital gastrointestinal anomalies or known chronic gastrointestinaldiseases requiring ongoing prescription therapy (e.g., Hirschsprung disease,inflammatory bowel disease, short-bowel syndrome).

• Clinically unstable condition or severe/critical illness that could interfere withparticipation or safety in the opinion of the investigator.

• Known or suspected primary or secondary immunodeficiency, or currentimmunosuppressive therapy.

• History of severe allergy or hypersensitivity to components of the investigationalproduct.

• Recent use of systemic antibiotics within 14 days prior to baseline, or use ofprobiotic supplements within 14 days prior to baseline (per protocol).

• Participation in another interventional clinical trial within 30 days prior toenrollment or during the study.

• Any condition that, in the investigator's judgment, would make the participantunsuitable for the study or confound outcome assessments.