RecruitingNot Applicable

Prevalence of FGIDs and Probiotics Study

Thailand512 participantsStarted 2024-03-14

Plain-language 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.

Who can participate

Age range

3 Days – 1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy and term (GA 37-41 weeks) infants
. Appropriate weight for age
. APGAR score more than 8 at 10 minutes of life
. Normal physical examination
. Mothers have no previous probiotics use

Exclusion criteria

. not willing to anticipate in the study
. cannot come to follow-up until 1 year of age

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The prevalence of functional gastrointestinal disorders in the treatment group

Timeframe: at birth, 1 month, 2 months, 4 months

Trial details

NCT IDNCT06309199

SponsorChulalongkorn University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02

Contact for this trial

Palittiya Sintusek, PhD

+66818288082 palittiya.s@chula.ac.th

View on ClinicalTrials.gov More Functional Gastrointestinal Disorders trials