Efficacy of a Low FODMAP Diet in IBS Children and Impact on Microbiota, Urinary and Faecal Metabolome

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by abdominal pain associated with defecation, or changes in stool frequency or stool form . The low FODMAPs diet (LFD) is a relatively new approach in the management of IBS and focuses on limiting intake of poorly absorbed carbohydrates. FODMAPs are highly fermentable but poorly absorbed short-chain carbohydrates and polyols contained in a wide variety of foods. FODMAPs include oligosaccharides (fructans, fructo-oligosaccharides = FOS and galacto-oligosaccharides = GOS), disaccharides (lactose), monosaccharides (fructose), and polyols (sorbitol, mannitol, maltitol, xylitol, polydextrose, and isomalt). Many studies and meta-analysis in adults have shown that a low FODMAPs diet is effective in reducing IBS symptoms, particularly bloating and abdominal pain. On the other hand, evidences in children are scarce. Previous studies in adults have demonstrated differences in urine metabolites between IBS patients receiving LFD compared to a high FODMAP diet (HFD), providing interesting hypotheses for pathophysiological mechanisms in IBS. Aim of this study is to evaluate the efficacy of a LFD on gastrointestinal symptoms in children with IBS. Moreover, the investigators will assess the impact of LFD vs a diet with a standard content of FODMAPs (SFD) on the fecal and urinary metabolomic profile of pediatric IBS patients. This is a single center, prospective, single blind low versus standard FODMAPs diet trial with crossover performed at Pediatric Gastroenterology Unit at the University of Bari. The trial includes four phases (run-in, low FODMAP diet, wash out and standard FODMAP diet). The run-in phase (weeks 1-2) aim to assess basal symptoms while on habitual diet and only symptomatic children (VAS\>3) will progress to the dietetic intervention trial. Then patients will be randomized to low or standard FODMAP diet for 14 days; then, children from both arms start the wash-out period of two weeks and subsequently start the final 2-week period on standard or low FODMAP diet.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 17
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
Italy
Pediatric Department B Trambusti Ospedale Giovanni XXIII Via Amendola 270
RECRUITING
Bari
Contact Information
Primary
Ruggiero Francavilla, Prof
rfrancavilla@gmail.com
0805592063
Backup
fernanda cristofori, MD
fernandacristofori@gmail.com
3384176598
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 30
Treatments
Active_comparator: LOW FODMAP-wash out- STANDARD FODMAPs
Arm starting with low fodmap diet
Active_comparator: STANDARD FODMAPs-wash out-LOW FODMAP
Arm starting with standard fodmap diet
Related Therapeutic Areas
Sponsors
Leads: University of Bari

This content was sourced from clinicaltrials.gov

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