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Completed

NCT Number: NCT05396651

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

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

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Ain Shams University

Cairo, Abbasia, 1234, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low fodmap diet

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 for IBS

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.

Primary outcomes

  1. improvement of irritable bowel syndrome symproms

    Time frame: 6 weeks

    Change in Pediactric Quality of life inventory (PedsQL) gastrointestinal symptoms module score

Secondary outcomes

  1. improve patients quality of life

    Time frame: 6 weeks

    Change in Pediatric quality of life inventory (PEDSQL) Generic core l score

Sponsors and collaborators

Lead sponsor

Sarah Abdelrahman El Ezaby

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 31, 2022
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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