Effect of Low Fodmap Diet on Control of Pediatric Irritable Bowel Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- improvement of irritable bowel syndrome symproms
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 5 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: low fodmap diet (Other)
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
Intervention: NICE guidelines for IBS (Other)
Outcomes
Primary Outcomes
improvement of irritable bowel syndrome symproms
Time Frame: 6 weeks
Change in Pediactric Quality of life inventory (PedsQL) gastrointestinal symptoms module score
Secondary Outcomes
- improve patients quality of life(6 weeks)
Investigators
Sarah Abdelrahman El Ezaby
Family Medicine assistant lecturer at Faculty of Medicine
Ain Shams University