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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05396651
• Other study ID #: FMASU319/2019
• Status: Completed
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: May 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 30, 2022
• Est. primary completion date: June 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Ain Shams University	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Sarah Abdelrahman El Ezaby

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of irritable bowel syndrome symproms	Change in Pediactric Quality of life inventory (PedsQL) gastrointestinal symptoms module score	6 weeks
Secondary	improve patients quality of life	Change in Pediatric quality of life inventory (PEDSQL) Generic core l score	6 weeks