WithdrawnNot Applicable

Mindfulness Training Versus Low (FODMAP) Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols Diet

Stopped: The study was withdrawn prior to initiation. No participants were enrolled.

0Started 2026-05

Plain-language summary

The study aims to compare the effect of mindfulness-based awareness training in Irritable Bowel Syndrome (IBS) (MB-IBS-EAT) with the dietary standard of care (low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet) on patient's IBS symptoms

Who can participate

Age range

18 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: * Aged 18 and over * Meets Rome IV criteria for diagnosis of Irritable Bowel Syndrome (IBS) * Has legal and mental capacity to understand and sign an informed consent document * Access to a computer or smart device with internet Exclusion Criteria: * Pregnancy * Active malignancy in the previous five years * Current or prior history of alcohol or drug abuse as defined by clinician * Any history of eating disorder such as anorexia or bulimia * Taking yoga or with prior history of mindfulness therapy within 3 months of enrollment * Currently on a fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet * Psychiatric illnesses other than depression or anxiety disorder * Nausea or vomiting

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

Global Improvement Scale (GIS) Scores Baseline

Timeframe: Baseline

Global Improvement Scale (GIS) Scores Week 1

Timeframe: Week 1

Global Improvement Scale (GIS) Scores Week 4

Timeframe: Week 4

Global Improvement Scale (GIS) Scores Week 8

Timeframe: Week 8

Global Improvement Scale (GIS) Scores Week 12

Timeframe: Week 12

Trial details

NCT IDNCT05630703

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

View on ClinicalTrials.gov More Irritable Bowel Syndrome (IBS) trials