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

NCT07148583 | Recruiting

• 2 other identifiers: CTBE.25.03Protocol No.: CTBE.25.03
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline to Day 42

• 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.

  Baseline to Day 42

Secondary Outcomes (5)

• Change in Stool Frequency Based on Infant & Toddler GI Symptom Questionnaire from Baseline to Day 42

  Baseline to Day 42

• Change in Stool Consistency Using the Brussels Infant and Toddler Stool Scale (BITSS) from Baseline to Day 42

  Up to Day 42

• Stool Microbiome - Between-Group Difference in Beta Diversity (PERMANOVA)

  Day 42

• Change in Frequency of Regurgitation and Vomiting Episodes from Baseline to Day 42

  Baseline to Day 42

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

  Baseline to Day 42

Study Arms (2)

BioAmicus Complete + Usual Care

EXPERIMENTAL

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)

Usual Care Alone

ACTIVE COMPARATOR

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

Usual Care (No Probiotic) OTHER

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

BioAmicus Complete + Usual Care; Usual Care Alone

BioAmicus Complete DIETARY_SUPPLEMENT

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)

BioAmicus Complete + Usual Care

Eligibility Criteria

• Age: 0 Days - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haiphong University of Medicine and Pharmacy: lead

Study Sites (1)

Clinical Trial and Bioequivalence Center

Haiphong, Hai Phong, 180000, Vietnam

RECRUITING

MeSH Terms

Conditions

Colic; Gastroesophageal Reflux; Dysbiosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Nguyen Thi Thu Phuong, MD, PhD

CONTACT

+84936685007; nttphuong@hpmu.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, single-center trial in infants 0-24 months comparing BioAmicus Complete plus usual care versus usual care.

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: September 5, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting materials will become available \~6 months after publication of the primary results and will remain available for 36 months thereafter. Earlier access may be granted for bona fide regulatory or public health needs. Extensions beyond 36 months will be considered upon reasonable request.
• Access Criteria: Access is available to qualified researchers with a methodologically sound proposal and, where applicable, IRB/ethics approval or waiver. Submit requests to the study contacts listed in this record, including a brief proposal and analysis plan. Approved requestors must sign a Data Use Agreement; data will be provided via secure transfer. Data may be used only for the approved objectives; re-identification is prohibited; citation of the original study is required; data must be destroyed or returned at the end of the access period.

Locations

VN (1)