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

Browse trials for

• Colic 148
• Gastroesophageal Reflux 1,063
• Dysbiosis 184

Keywords

• BioAmicus Complete
• probiotic
• multistrain probiotic
• infant
• functional gastrointestinal symptoms
• Infant Gastrointestinal Symptom Questionnaire
• gut microbiome
• stool microbiome

Study arms

• Experimental
  BioAmicus Complete + Usual Care

  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.

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

• Active comparator
  Usual Care Alone

  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.

  Other: Usual Care (No Probiotic)

Interventions

• Dietary supplementBioAmicus Complete

  Oral 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.

  Also known as: Multistrain Probiotic (BioAmicus Complete)

• OtherUsual Care (No Probiotic)

  Standard 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.

  Also known as: Standard care, Routine clinical management

Primary outcomes

1. 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

   Time frame: Baseline to Day 42

2. 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.

   Time frame: Baseline to Day 42

Secondary outcomes

1. 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).

   Time frame: Baseline to Day 42

2. 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.

   Time frame: Up to Day 42

3. 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.

   Time frame: Day 42

4. 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.

   Time frame: Baseline to Day 42

5. Change in Colic Symptoms Based on Infant & Toddler GI Symptom Questionnaire from Baseline to Day 42

   Colic is assessed, based on Wessel's criteria (≥3 hours/day, ≥3 days/week, for ≥3 weeks). Responses are scored on a binary scale (Yes/No). Presence of colic is considered a positive outcome at baseline. Improvement is defined as resolution of criteria (reduction below threshold)

   Time frame: Baseline to Day 42

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) underlying the primary and secondary outcomes will be shared. Datasets will include: baseline characteristics; IGSQ item and total scores; caregiver diary data (stool frequency/form, regurgitation/vomiting counts, crying/irritability duration); growth parameters; concomitant medications; protocol deviations; and safety data (TEAEs/SAEs, relatedness, severity). For microbiome analyses, processed data (e.g., feature/ASV tables, relative abundance matrices, and diversity indices) will be shared; raw sequencing reads may be available on justified request. A data dictionary and variable codebook will accompany the IPD.

Supporting information: Study protocol, Sap, Icf