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

Effect of Low Fodmap Diet on Control of Pediatric Irritable Bowel Syndrome

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

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Other: low fodmap diet; Other: NICE guidelines for IBS

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 1234
      • Faculty of Medicine Ain shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LOW FODMAP Diet group; 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	Other: low fodmap diet; elimination of high fodmap diet - High FODMAP diet: ice cream, soft cheese , yoghurt, cabbage , cauliflower, green bean, garlic, okra, onions, snow peas, broccoli, avocado , apple, mango , dates, watermelon, legumes , pulses, wheat , pasta , artificial sweeteners
PLACEBO_COMPARATOR: NICE guidelines group; 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	Other: NICE guidelines for IBS; follow NICE guidelines for IBS :have regular meals and take time to eat. avoid missing meals or leaving long gaps between eating. drink at least 8 cups of fluid per day, especially water or other non-caffeinated drinks, for example herbal teas. restrict tea and coffee to 3 cups per day. reduce intake of alcohol and fizzy drinks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement of irritable bowel syndrome symproms	Change in Pediactric Quality of life inventory (PedsQL) gastrointestinal symptoms module score	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improve patients quality of life	Change in Pediatric quality of life inventory (PEDSQL) Generic core l score	6 weeks

Collaborators and Investigators

• Sponsor: Sarah Abdelrahman El Ezaby
• Investigators: Study Director: Diaa a Marzouk, professor, Faculty of Medicine Ain shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2020
• Primary Completion (ACTUAL): June 13, 2021
• Study Completion (ACTUAL): January 30, 2022

Study Registration Dates

• First Submitted: March 6, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (ACTUAL): May 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: FMASU319/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No