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

NCT ID: NCT05396651

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-02
• Study Completion Date: 2022-01-30

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

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

low fodmap diet

Intervention Type: OTHER

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

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

Group Type: PLACEBO_COMPARATOR

NICE guidelines for IBS

Intervention Type: OTHER

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.

Interventions

low 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

Intervention Type: OTHER

NICE 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sarah Abdelrahman El Ezaby

OTHER

Sponsor Role: lead

Responsible Party

Sarah Abdelrahman El Ezaby

Family Medicine assistant lecturer at Faculty of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Diaa a Marzouk, professor

Role: STUDY_DIRECTOR

faculty of medicine ain shams university

Locations

Faculty of Medicine Ain Shams University

Cairo, Abbasia, Egypt

Countries

Egypt

Other Identifiers

FMASU319/2019

Identifier Type: -

Identifier Source: org_study_id