Low FODMAP diet for children with IBS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.