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.
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.
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.
Parallel
BioAmicus Complete
Dietary supplementOral liquid probiotic (multistrain) administered by caregivers per protocol/label for 42 days to infants with functional GI symptoms. Given as drops by mouth; dosing and administration instructions per protocol. No other probiotic products allowed during the study. Concomitant medications and routine management may be used as clinically indicated. Adherence is recorded; lot/batch number captured.
Usual Care (No Probiotic)
Other interventionStandard clinical management for infant functional gastrointestinal symptoms per local practice. No probiotic supplementation is provided during the study period. Participants follow the same visit and assessment schedule as the intervention arm. Concomitant medications and supportive care may be used as clinically indicated.
Change from Baseline in Infant Gastrointestinal Symptom Questionnaire (IGSQ) Total Score at Day 42
IGSQ is a 13-item, caregiver-reported questionnaire (total score 13-65; higher scores indicate worse symptoms). Change is calculated as Day 42 minus baseline; a negative change indicates improvement
Stool Microbiome - Change in Alpha Diversity (Shannon, Chao1)
16S rRNA gene sequencing of stool at baseline and Day 42; alpha diversity indices computed and change analyzed within and between groups.
Change in Stool Frequency Based on Infant & Toddler GI Symptom Questionnaire from Baseline to Day 42
Stool frequency is assessed. Responses range from 1 (≤2 times/week) to 5 (\>3 times/day). Higher scores indicate more frequent bowel movements (diarrhea tendency), while lower scores indicate infrequent stools (constipation). Improvement is defined as movement toward the normal category (1 bowel movement/day).
Change in Stool Consistency Using the Brussels Infant and Toddler Stool Scale (BITSS) from Baseline to Day 42
Stool consistency is assessed using the Brussels Infant and Toddler Stool Scale (BITSS), with five categories: 1 = watery, 2 = soft, 3 = formed, 4 = hard, 5 = inconsistent. Category 3 (formed) is considered normal. Scores below 3 represent looser stools (diarrhea tendency), while scores above 3 represent harder stools (constipation tendency). Improvement is defined as a ≥1-category change toward formed stool.
Stool Microbiome - Between-Group Difference in Beta Diversity (PERMANOVA)
Bray-Curtis and UniFrac distances used to assess community differences between groups; hypothesis testing via PERMANOVA.
Change in Frequency of Regurgitation and Vomiting Episodes from Baseline to Day 42
Regurgitation and vomiting are assessed using Questions. Frequency is reported on a 7-point ordinal scale (0 = never to 6 = \>5 times/day). Higher scores indicate more frequent regurgitation/vomiting (worse outcome). Improvement is defined as a reduction of ≥1 category on the frequency scale.
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