Clinical Trial

Prevalence of FGIDs and Probiotics Study

Study acronym: PROOF
Recruiting
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Record status
This record was last updated July 2, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-03-06; most recent amendment 2025-06-28.
Status change: Not Yet Recruiting → Recruiting 2024-08-19
Trial Details
NCT Number NCT06309199
Lead Sponsor Chulalongkorn University
Conditions Functional Gastrointestinal Disorders, Infant Conditions
Enrollment 512 participants
Start Date 2024-03-14
Primary Completion 2026-02 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2025-07-02