Actively Recruiting
Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology
Led by Chulalongkorn University · Updated on 2025-07-02
512
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying healthy infants to understand how common functional gastrointestinal disorders (FGIDs) are using a Thai version of the Rome IV questionnaire. They are also evaluating whether the probiotic Limosilactobacillus reuteri DSM 17938 can help prevent these gastrointestinal issues and how it affects gut microbiota diversity. The study involves infants born at a hospital in Bangkok and aims to gather detailed data about FGIDs and related factors. Participants are randomly assigned to receive either the probiotic Limosilactobacillus reuteri DSM 17938 or a placebo made of sunflower oil and MCT oil. Each infant will get 5 drops daily for about 60 days. The study includes five visits at birth, 1, 2, 4, and 12 months of age, where health checks, questionnaires, and stool samples are collected. Researchers will analyze the results after the 4-month follow-up and continue monitoring through telephone questionnaires up to 9 months. During the study, infants' stool samples will be collected at each visit to analyze gut bacteria using DNA techniques. Demographic information and responses to the Rome IV questionnaire will be recorded to track FGIDs. Researchers will monitor the infants' health and growth and maintain the stool samples for up to 10 years for future analysis. The study is planned to end in February 2026, with ongoing follow-up to better understand FGIDs and probiotic effects in infants.
CONDITIONS
Brief Title
Prevalence of FGIDs and Probiotics Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy and term infants born between 37 and 41 weeks gestation
- Appropriate weight for age
- APGAR score greater than 8 at 10 minutes after birth
- Normal physical examination
- Mothers have no previous probiotics use
You will not qualify if you...
- Not willing to participate in the study
- Unable to attend follow-up visits until 1 year of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to birth
Participants are screened for eligibility to participate in the trial.
1 visit (at birth)
Duration - Approximately 60 days
Participants receive either probiotics or placebo daily for about 60 days to study their effects on functional gastrointestinal disorders.
Visits at 1 and 2 months of age
Duration - Up to 12 months of age
Participants are monitored with questionnaires, physical exams, and stool collections to assess prevalence of gastrointestinal disorders and gut microbiota diversity.
Visits at 4 and 12 months of age plus telephone follow-ups at 3, 6, and 9 months
Trial Site Locations
Total: 1 location
1
Maha Chakri Sirindhorn Clinical Research Center (Chula CRC)
Bangkok, Bangkok, Thailand, 10330
Actively Recruiting
Research Team
P
Palittiya Sintusek, PhD
S
Sittichoke Prachuapthunyachart, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here