Evaluating probiotics for preventing gastrointestinal disorders in infants
Center of Excellence in Thai Pediatric Gastroenterology, Hepatology and Immunology
This study is testing if giving a specific probiotic to healthy infants can help prevent tummy troubles and improve their gut health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 512 (estimated) |
| Ages | 3 Days to 1 Year |
| Sex | All |
| Sponsor | Chulalongkorn University Academic / other |
| Locations | 1 site (Bangkok, Bangkok) |
| Trial ID | NCT06309199 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the prevalence of functional gastrointestinal disorders (FGIDs) in infants and evaluate the efficacy of Limosilactobacillus reuteri DSM 17938 in preventing these disorders. It utilizes the Thai version of the Rome IV diagnostic questionnaire to identify FGIDs in healthy infants. The study involves a randomized controlled trial design, where participants receive either the probiotic or a placebo for 60 days, with follow-up assessments at various intervals. The research will also analyze the impact of the intervention on gut microbiota diversity.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy, term infants born at King Chulalongkorn Memorial Hospital who meet specific health criteria.
Not a fit: Patients who may not benefit from this study include those with pre-existing gastrointestinal disorders or those unable to attend follow-up visits.
Why it matters
Potential benefit: If successful, this study could provide a preventive approach to managing gastrointestinal disorders in infants, potentially improving their overall health and comfort.
How similar studies have performed: Other studies have shown promising results with probiotics in managing gastrointestinal disorders, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy and term (GA 37-41 weeks) infants 2. Appropriate weight for age 3. APGAR score more than 8 at 10 minutes of life 4. Normal physical examination 5. Mothers have no previous probiotics use Exclusion Criteria: 1. not willing to anticipate in the study 2. cannot come to follow-up until 1 year of age
Where this trial is running
Bangkok, Bangkok
- Maha Chakri Sirindhorn Clinical Research Center (Chula CRC) — Bangkok, Bangkok, Thailand (Recruiting)
Study contacts
- Study coordinator: Palittiya Sintusek, PhD
- Email: palittiya.s@chula.ac.th
- Phone: +66818288082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.