Low FODMAP diet for children with IBS
Efficacy of a Low FODMAP Diet in IBS Children and Impact on Microbiota, Urinary and Faecal Metabolome
This study is testing if a low FODMAP diet can help children with irritable bowel syndrome feel better compared to a regular diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | University of Bari Academic / other |
| Locations | 1 site (Bari, Ba) |
| Trial ID | NCT06618677 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a low FODMAP diet in children diagnosed with irritable bowel syndrome (IBS). It is a single-center, prospective, single-blind trial that includes a crossover design, allowing participants to experience both low and standard FODMAP diets. The trial consists of four phases: a run-in phase to assess baseline symptoms, followed by a 14-day intervention with either a low or standard FODMAP diet, a wash-out period, and then a final 2-week period on the alternate diet. Metabolomic analysis of fecal and urinary samples will be conducted to evaluate changes in metabolite profiles associated with dietary interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 to 18 years who have been diagnosed with IBS according to the Rome IV criteria.
Not a fit: Patients with other organic diseases, certain functional gastrointestinal disorders, or those who have previously followed an exclusion diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary management option that significantly alleviates IBS symptoms in children.
How similar studies have performed: Previous studies in adults have shown success with low FODMAP diets in managing IBS symptoms, but evidence in children is limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: a) age between 4 and 18 years; b) diagnosis of IBS according to Rome IV criteria; c) absence of other organic diseases; d) feeding via the oral route; e) ability to read and comprehend any employed questionnaires/scales; f) signed informed consent; Exclusion Criteria: a) organic disease b)some other FGID (not IBS) or lactose intolerance c) having already followed an exclusion diet d)in case of pregnancy e)eating disorders f) prior surgery of the gastrointestinal tract g) neurodevelopmental disabilities
Where this trial is running
Bari, Ba
- Pediatric Department "B Trambusti" Ospedale Giovanni XXIII Via Amendola 270 — Bari, Ba, Italy (Recruiting)
Study contacts
- Principal investigator: Ruggiero Francavilla, Prof — Interdisciplinary department of Medicine Pediatric section. University of Bari Aldo Moro
- Study coordinator: Ruggiero Francavilla, Prof
- Email: rfrancavilla@gmail.com
- Phone: 0805592063
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.