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CompletedNCT05396651Updated Jun 1, 2022

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

An interventional study of low fodmap diet and NICE guidelines for IBS in Irritable Bowel Syndrome, sponsored by Sarah Abdelrahman El Ezaby. Completed at 1 site in Egypt. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2022-06-01.

Sponsored by Sarah Abdelrahman El Ezaby · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Oct 2020, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
5 Years to 15 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Irritable Bowel Syndrome
03

In context

Irritable Bowel Syndrome

1,084 studies on the registry are indexed under Irritable Bowel Syndrome; 196 are open to participants now.

This study's enrollment of 80 is above the median of 70 across 869 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

This is the only study on the registry with Sarah Abdelrahman El Ezaby as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Otherlow 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

  • OtherNICE 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.

06

What researchers measure

Primary outcomes

  1. improvement of irritable bowel syndrome symproms

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

    Time frame: 6 weeks

Secondary outcomes

  1. improve patients quality of life

    Change in Pediatric quality of life inventory (PEDSQL) Generic core l score

    Time frame: 6 weeks

07

Study locations

1 site
  • Faculty of Medicine Ain Shams University
    Cairo, Abbasia 1234, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05396651
Lead sponsor
Sarah Abdelrahman El Ezaby
Responsible party
Sarah Abdelrahman El Ezaby (Family Medicine assistant lecturer at Faculty of Medicine, Ain Shams University) — Sponsor-investigator
First posted
May 31, 2022
Start date
Oct 2, 2020
Primary completion
Jun 13, 2021
Completion
Jan 30, 2022
Last update
Jun 1, 2022

Study contacts

Diaa a Marzouk, professor
study director · faculty of medicine ain shams university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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