The Effect of Low-FODMAP Diet on Leaky Gut ,Symptoms and Quality of Life in Patient With Irritable Bowel Syndrome
Phase: NA
Conditions: Irritable Bowel Syndrome
Sponsor: Istanbul Medipol University Hospital

Study Protocol
Official Title: The Effect of a Low-FODMAP Diet on Leaky Gut, Symptoms, and Quality of Life in Patients
with Irritable Bowel Syndrome
NCT Number: (to be added after registration)
Document Date: March 2026

Background
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder
characterized by recurrent abdominal pain and altered bowel habits. Dietary interventions,
particularly the Low-FODMAP diet, have been shown to improve symptoms in IBS patients.
The impact of this diet on intestinal permeability (“leaky gut”) remains unclear.
Objective
To evaluate the effect of a Low-FODMAP diet on intestinal permeability,
symptom severity, and quality of life in patients with IBS.
Study Design
Prospective, randomized, single-blind clinical study conducted at
Istanbul Medipol Mega University Hospital between December 2023 and December 2024.
Participants
Adults aged 18–65 years diagnosed with IBS according to Rome IV criteria
presenting to Internal Medicine or Gastroenterology outpatient clinics.
Interventions
Participants are randomized into two groups:
1. Low-FODMAP diet group
2. Traditional diet group
Dietary adherence is monitored through weekly diet diaries and consultations with a dietitian.
Outcome Measures
Primary outcomes include changes in IBS Symptom Severity Score (IBSISSS).
Secondary outcomes include changes in IBS Quality of Life (IBSIQOL) scores and fecal zonulin levels.
Follow-up
Measurements are performed at baseline, week 4, and week 16
(for the Low-FODMAP group after gradual food reintroduction).

Statistical Analysis
Data will be analyzed using SPSS version 27. Continuous variables will be
reported as mean ± standard deviation or median values. Appropriate parametric or nonparametric tests
will be used depending on data distribution. Statistical significance will be set at p < 0.05.
Ethics
The study protocol was approved by the Istanbul Medipol University NonIInterventional
Clinical Research Ethics Committee. Written informed consent was obtained from all participants.