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

Sarah Abdelrahman El Ezaby

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Other: low fodmap diet; Other: NICE guidelines for IBS

Study type: Interventional

Funder types: Other

Identifiers

NCT05396651

FMASU319/2019

Details and patient eligibility

About

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

Full 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

Enrollment: 80 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

LOW FODMAP Diet group

Experimental group

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

Treatment:

Other: low fodmap diet

NICE guidelines group

Placebo Comparator group

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

Treatment:

Other: NICE guidelines for IBS