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Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology (PROOF)
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.
Details
| Lead sponsor | Chulalongkorn University |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 512 |
| Start date | 2024-03-14 |
| Completion | 2026-02 |
Conditions
- Functional Gastrointestinal Disorders
- Infant Conditions
Interventions
- Biogaia
- Placebo
Primary outcomes
- The prevalence of functional gastrointestinal disorders in the treatment group — at birth, 1 month, 2 months, 4 months
Functional gastrointestinal disorders (colic, regurgitation, constipation, dyschazia and rumination) were assessed using the Thai version of Rome IV diagnostic questionnaire for neonates and toddlers
Countries
Thailand