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(FODMAP) Diet on Improving Symptoms of Patients With Irritable Bowel Syndrome

NCT07299305 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2025-12-23

No results posted yet for this study

Summary

Irritable bowel syndrome (IBS) is a common disorder of gut-brain interaction, characterized by chronic abdominal pain and altered bowel habits. A low-FODMAP diet (LFD), which restricts specific types of fermentable carbohydrates, significantly reduces IBS symptoms and improves quality of life (QoL). Objectives: To evaluate the short- and long-term effects of LFD on improving symptom severity and the quality of life of IBS patients attending the family medicine outpatient clinic, and to assess LFD acceptability and adherence of IBS patients. Methods: Randomized control trial conducted on (123 patients) with IBS attending outpatient clinic of family medicine at Tenth of Ramadan University Hospital from 1st of June 2024 to the end of June 2025. An intervention group (No=93) received patient-centered education about LFD, and a control group (No.=90). Participants in both groups underwent an assessment of their BMI, Irritable Bowel Syndrome- Severity Scoring System (IBS-SSS), and irritable bowel syndrome-Quality of Life Measure (IBS-QOL) preintervention during the first visit and reassessed post-intervention after one, three, and six months. Additionally, Patients in the intervention group were assessed for the FODMAP Adherence Report Scale (FARS), LFD acceptability questionnaire, and Food-related QOL questionnaire at one, three-, and six-month post-intervention phases.

Conditions

  • Irritable Bowel Disease

Interventions

DIETARY_SUPPLEMENT

Low Fermentable, Oligo-, Di-, Monosaccharides and Polyols (FODMAP) Diet

The intervention group was subjected to the intervention (health education about LED) . It was conducted through patient-centered educational sessions and follow-up visits in the form of a personal interview and one to one discussion. Participants' phone number was taken for follow-up. Every 2 weeks, the patients were contacted by telephone to resolve any problems related to dietary management. The educational booklet was handled to the patient, it contained all details about how to apply the low FODMAP diet. The message delivered contained information about: Definition of IBS, diagnosis of IBS, red flags of IBS, management of IBS and role and component of low FODMAP diet in IBS. The control group received the educational booklet at the end of the study for ethical purposes.Patients in the intervention group only were asked to fill out the 3 questionnaires related to food acceptability and adherence: FODMAP Adherence Report Scale (FARS), LFD acceptability questionnaire and Food

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Hanaa A Nofal, MD · Zagazig University Faculty of Human Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-06-30
Completion
2025-10-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07299305 on ClinicalTrials.gov