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

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Low Fodmap Diet on Control of Pediatric Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: low fodmap diet
* Other: NICE guidelines for IBS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LOW FODMAP Diet group<br>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<br>* 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<br>|
| Placebo Comparator: NICE guidelines group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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