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

NCT07467278 | Not Yet Recruiting

• 1 other identifier: IstanbulMUH-IM-EC-01
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irritable Bowel Syndrome

Keywords

IBS,FODMAP DIET,ZONULIN

Outcome Measures

Primary Outcomes (1)

• change zonulin levels in IBS patient

  We aim to investigate that lox fodmap diet has decreased stool zonulin level and improve leaky gut or not

  after started diet 4 weeks later and after modified low fodmap diet 8 weeks later check stool analyse again

Study Arms (2)

low fodmap diet

EXPERIMENTAL

Dietary Intervention,low fodmap diet

Other: low fodmap diet

traditional diet

ACTIVE COMPARATOR

traditional diet

Other: dietary intervention

Interventions

low fodmap diet OTHER

experimental group consume low fodmap diet

Also known as: diet

low fodmap diet

dietary intervention OTHER

dietary interventionlow fodmap diet

traditional diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Medipol University: collaborator

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet; Diet; Diet Therapy

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Nutrition Therapy; Therapeutics

Central Study Contacts

Esra Demir, Assoc.Prof.

CONTACT

00905366161365; esracokicli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.Dr.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share