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Low-FODMAP Diet and Intestinal Permeability in Patients With Irritable Bowel Syndrome

The Effect of Low-FODMAP Diet on Leaky Gut ,Symptoms and Quality of Life in Patient With Irritable Bowel Syndrome

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07467278
Enrollment
24
Registered
2026-03-12
Start date
2026-03-15
Completion date
2026-08-30
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

IBS,FODMAP DIET,ZONULIN

Brief summary

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

OTHERlow fodmap diet

experimental group consume low fodmap diet

OTHERdietary intervention

dietary interventionlow fodmap diet

Sponsors

Istanbul Medipol University Hospital
Lead SponsorOTHER
Medipol University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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%) \-

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

Design outcomes

Primary

MeasureTime frameDescription
change zonulin levels in IBS patientafter started diet 4 weeks later and after modified low fodmap diet 8 weeks later check stool analyse againWe aim to investigate that lox fodmap diet has decreased stool zonulin level and improve leaky gut or not

Contacts

CONTACTEsra Demir, Assoc.Prof.
esracokicli@gmail.com00905366161365

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026