Back to resultsEffect of Low Fermentable Oligosaccharides, Disaccharides ,Monosaccharides and Polyols (FODMAP) Diet on Control of Pediatric Irritable Bowel Syndrome and Quality of Life
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
low fodmap diet
NICE guidelines for IBS
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LOW FODMAP Diet group
NICE guidelines group
Arm Description
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
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
Outcomes
Primary Outcome Measures
improvement of irritable bowel syndrome symproms
Change in Pediactric Quality of life inventory (PedsQL) gastrointestinal symptoms module score
Secondary Outcome Measures
improve patients quality of life
Change in Pediatric quality of life inventory (PEDSQL) Generic core l score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05396651
Brief Title
Effect of Low Fermentable Oligosaccharides, Disaccharides ,Monosaccharides and Polyols (FODMAP) Diet on Control of Pediatric Irritable Bowel Syndrome and Quality of Life
Official Title
Effect of Low Fodmap Diet on Control of Pediatric Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
June 13, 2021 (Actual)
Study Completion Date
January 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sarah Abdelrahman El Ezaby
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LOW FODMAP Diet group
Arm Type
Experimental
Arm Description
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
Arm Title
NICE guidelines group
Arm Type
Placebo Comparator
Arm Description
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 Type
Other
Intervention Name(s)
low fodmap diet
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
NICE guidelines for IBS
Intervention Description
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.
Primary Outcome Measure Information:
Title
improvement of irritable bowel syndrome symproms
Description
Change in Pediactric Quality of life inventory (PedsQL) gastrointestinal symptoms module score
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
improve patients quality of life
Description
Change in Pediatric quality of life inventory (PEDSQL) Generic core l score
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diaa a Marzouk, professor
Organizational Affiliation
faculty of medicine ain shams university
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine Ain Shams University
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
1234
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Low Fermentable Oligosaccharides, Disaccharides ,Monosaccharides and Polyols (FODMAP) Diet on Control of Pediatric Irritable Bowel Syndrome and Quality of Life
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