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

NCT07148583 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-01-29

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

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.

Sponsors & Collaborators

  • Haiphong University of Medicine and Pharmacy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-05
Primary Completion
2026-04-30
Completion
2026-05-30

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148583 on ClinicalTrials.gov