Effect of Low Fermentable Oligosaccharides, Disaccharides ,Monosaccharides and Polyols (FODMAP) Diet on Control of Pediatric Irritable Bowel Syndrome and Quality of Life

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: low fodmap diet; Other: NICE guidelines for IBS

• Registration Number: NCT05396651
• Lead Sponsor: Sarah Abdelrahman El Ezaby

Brief Summary

To evaluate the impact of low FODMAP diet on Health related Quality of life in children with Irritable bowel syndrome according to ROME IV criteria in a group of patients in pediatric Hospital at Ain Shams University

Detailed Description

Single blinded randomized two-arm intervention study in which 42 patients with irritable bowel syndrome were enrolled to study the effect of LOW FODMAP diet ( intervention group) on their gastrointestinal symptoms and their quality of life another group of 42 patients of IBS were enrolled as a control group who were received general diet instructions and they followed the NICE guide lines for IBS management

Study Timeline

• Study Start: 2020-10-02
• Primary Completion: 2021-06-13
• Study Completion: 2022-01-30
• Study First Submitted: 2022-03-06
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-25
• Last Update Submitted: 2022-05-27
• Study First Posted: 2022-05-31
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis

Exclusion Criteria

Patients presenting with :

• Abdominal pain or diarrhea that wakes the child from sleep
• Delay in onset or progression of puberty.
• Faltering growth.
• Family history of inflammatory bowel disease, celiac disease.
• History of significant weight loss .
• Bleeding per rectum.
• Persistence of severe vomiting or diarrhea
• . Persistent joint pain.
• Recurrent unexplained fever.
• Unexplained pallor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LOW FODMAP Diet group	low fodmap diet	42 Children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis, and didn't have any of the following :o Abdominal pain or diarrhea that wakes the child from sleep * Delay in onset or progression of puberty. * Faltering growth. * Family history of inflammatory bowel disease, celiac disease. * History of significant weight loss . * Bleeding per rectum. * Persistence of severe vomiting or diarrhea * . Persistent joint pain. * Recurrent unexplained fever. * Unexplained pallor they followed the low fodmapdiet for 6 weeks
NICE guidelines group	NICE guidelines for IBS	42 Children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis and didn't have one of the following : o Abdominal pain or diarrhea that wakes the child from sleep * Delay in onset or progression of puberty. * Faltering growth. * Family history of inflammatory bowel disease, celiac disease. * History of significant weight loss . * Bleeding per rectum. * Persistence of severe vomiting or diarrhea * . Persistent joint pain. * Recurrent unexplained fever. * Unexplained pallor they followed NICE guidelines for irritable bowel syndrome for 6 weeks

Primary Outcome Measures

Name	Time	Method
improvement of irritable bowel syndrome symproms	6 weeks	Change in Pediactric Quality of life inventory (PedsQL) gastrointestinal symptoms module score

Secondary Outcome Measures

Name	Time	Method
improve patients quality of life	6 weeks	Change in Pediatric quality of life inventory (PEDSQL) Generic core l score

Trial Locations

Locations (1)

Faculty of Medicine Ain Shams University; 🇪🇬 Cairo, Abbasia, Egypt