Low-FODMAP Diet and Intestinal Permeability in Patients With Irritable Bowel Syndrome (NCT07467278) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Low-FODMAP Diet and Intestinal Permeability in Patients With Irritable Bowel Syndrome
24 participantsStarted 2026-03-15
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change zonulin levels in IBS patient
Timeframe: after started diet 4 weeks later and after modified low fodmap diet 8 weeks later check stool analyse again