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

NCT05396651 | Completed DMC

• 1 other identifier: FMASU319/2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• improvement of irritable bowel syndrome symproms

  Change in Pediactric Quality of life inventory (PedsQL) gastrointestinal symptoms module score

  6 weeks

Secondary Outcomes (1)

• improve patients quality of life

  6 weeks

Study Arms (2)

LOW FODMAP Diet group

EXPERIMENTAL

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

NICE guidelines group

PLACEBO COMPARATOR

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

Interventions

low fodmap diet OTHER

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

LOW FODMAP Diet group

NICE guidelines for IBS OTHER

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.

NICE guidelines group

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sarah Abdelrahman El Ezaby: lead

Study Sites (1)

Faculty of Medicine Ain Shams University

Cairo, Abbasia, 1234, Egypt

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Diaa a Marzouk, professor

  faculty of medicine ain shams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Family Medicine assistant lecturer at Faculty of Medicine

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: May 31, 2022
• Study Start: October 2, 2020
• Primary Completion: June 13, 2021
• Study Completion: January 30, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)