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Prevalence of FGIDs and Probiotics Study

NCT06309199 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2025-07-02

No results posted yet for this study

Summary

This is a study to evaluate the prevalence of FGIDs in infants using the Thai version of Rome IV diagnostic questionnaire for functional gastrointestinal disorders in infants and evaluate the efficacy of Limosilactobacillus reuteri DSM 17938 to prevent FGIDs in infants.

Conditions

  • Functional Gastrointestinal Disorders
  • Infant Conditions

Interventions

DIETARY_SUPPLEMENT

Biogaia

Biogaia is a probiotics product that contain Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil

OTHER

Placebo

Limosilactobacillus reuteri DSM 17938, sunflower oil and MCT oil

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Yong Poovorawan, MD · Center of Excellence in Clinical Virology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-14
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Thailand

Study Locations

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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 NCT06309199 on ClinicalTrials.gov