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

NCT ID: NCT07148583

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-05
• Study Completion Date: 2026-05-30

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BioAmicus Complete

Intervention Type: 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.

Usual Care (No Probiotic)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Usual Care (No Probiotic)

Intervention Type: 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.

Interventions

BioAmicus 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.

Intervention Type: DIETARY_SUPPLEMENT

Usual 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.

Intervention Type: OTHER

Other Intervention Names

Multistrain Probiotic (BioAmicus Complete); Standard care; Routine clinical management

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haiphong University of Medicine and Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial and Bioequivalence Center

Haiphong, Hai Phong, Vietnam

Site Status: RECRUITING

Countries

Vietnam

Central Contacts

Nguyen Thi Thu Phuong, MD, PhD

Role: CONTACT

nttphuong@hpmu.edu.vn

+84936685007

Facility Contacts

Van Anh Tran, MSc.Pharm

Role: primary

tvanh@hpmu.edu.vn

0343035492

Phuong Thi Thu Nguyen, MD, PhD

Role: backup

nttphuong@hpmu.edu.vn

Other Identifiers

Protocol No.: CTBE.25.03

Identifier Type: OTHER

Identifier Source: secondary_id

CTBE.25.03

Identifier Type: -

Identifier Source: org_study_id