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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05396651

Enrollment

Registered

2022-05-31

Start date

2020-10-02

Completion date

2022-01-30

Last updated

2022-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

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

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

5 Years to 15 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026