Low-FODMAP Diet and Intestinal Permeability in Patients With Irritable Bowel Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: low fodmap diet, dietary intervention.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Low-FODMAP Diet on Leaky Gut ,Symptoms and Quality of Life in Patient With Irritable Bowel Syndrome
Overview
This study aimed to evaluate the effects of a Low-FODMAP diet on intestinal permeability, symptom severity, and quality of life in patients with Irritable Bowel Syndrome (IBS). Twenty-four patients diagnosed with IBS according to the Rome IV criteria were randomized to either a Low-FODMAP diet or a traditional diet for four weeks. Stool zonulin family peptides (ZFP), IBS Symptom Severity Score (IBS-SSS), and IBS Quality of Life (IBS-QOL) questionnaires were recorded at baseline and after the dietary intervention. In the Low-FODMAP group, FODMAP-containing foods were gradually reintroduced under dietitian supervision, and assessments were repeated at week 16 to evaluate long-term effects.
Detailed description
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain and altered bowel habits without an identifiable organic cause. Dietary factors and increased intestinal permeability have been proposed as potential mechanisms contributing to symptom development.
The Low-FODMAP diet has been shown to improve IBS symptoms by reducing fermentable carbohydrate intake. However, its effects on intestinal barrier integrity remain unclear.
This prospective randomized single-blind study was conducted at Istanbul Medipol Mega University Hospital between December 2023 and December 2024. Patients aged 18-65 years diagnosed with IBS according to the Rome IV criteria were included. Participants were randomized to follow either a Low-FODMAP diet or a traditional diet for four weeks. Stool zonulin family peptides (ZFP) were measured as a biomarker of intestinal permeability. Symptom severity and quality of life were evaluated using validated IBS-SSS and IBS-QOL questionnaires.
After four weeks, patients in the Low-FODMAP group began a structured reintroduction phase where restricted foods were gradually reintroduced over twelve weeks. Follow-up assessments were performed at week 16 to evaluate long-term outcomes.
The study investigated whether dietary FODMAP restriction could improve intestinal barrier function in addition to reducing symptom severity and improving quality of life in patients with IBS.
Interventions
- Other low fodmap diet
experimental group consume low fodmap diet - Other dietary intervention
dietary interventionlow fodmap diet
Primary outcome measures
- change zonulin levels in IBS patient [Time frame: after started diet 4 weeks later and after modified low fodmap diet 8 weeks later check stool analyse again]
Eligibility criteria
Inclusion Criteria:Age between 18 and 65 years
Diagnosis of Irritable Bowel Syndrome (IBS) according to Rome IV criteria
Patients presenting to Internal Medicine or Gastroenterology outpatient clinics
Ability to provide written informed consent
Willingness to comply with the assigned dietary intervention and follow-up schedule
Patients who were mostly compliant or fully compliant with the dietary protocol (≥51%)
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Exclusion criteria
- IBS-specific treatment within the last 1 month
Antibiotic or probiotic use within the previous 2 weeks
History of major abdominal surgery
Active malignancy
Heart failure
Renal failure
Autoimmune disease
Inflammatory bowel disease
Celiac disease
Lactose intolerance
Individuals currently following another dietary regimen
Pregnancy
Poor adherence to diet protocol (<51%)
Failure to submit dietary diaries regularly
Need for antibiotic therapy during the intervention period
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07467278 · IstanbulMUH-IM-EC-01