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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-07-31

Brief Summary

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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

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Detailed Description

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This pilot study will be a randomized parallel trial comparing MB-IBS-EAT done over an 8-week period to a standard low FODMAP diet. The low FODMAP diet is currently employed by clinicians as a treatment for IBS, but response rates are poor, without documented long-term benefit. This finding supports the need for better, longer lasting interventions.

Conditions

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Irritable Bowel Syndrome (IBS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The randomization scheme used will be a random number generator using the Research Randomizer website (https://www.randomizer.org/) where the subjects will be randomized in one (1) of two (2) arms:

Mindfulness-based Awareness Training in IBS (MB-IBS-EAT) Intervention OR Low FODMAP Diet Intervention

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The principal investigator will be blinded for the duration of the study. The study psychologist and the dietician will be blinded to the study results for the duration of the study.

Study Groups

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Mindfulness Training

Behavioral: Mindfulness-based Eating Awareness Training in IBS - The MB-IBS-EAT is an 8-week intervention with weekly 1-hour sessions in a web-based group format.

Group Type EXPERIMENTAL

Mindfulness-based Attention Training in IBS

Intervention Type BEHAVIORAL

The MB-IBS-EAT is an 8-week intervention with weekly 1-hour sessions in a web-based group format.

fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet

Dietary: Low FODMAP Diet - Subjects in the FODMAP group will be provided dietary instructions by a registered dietician during weekly 1-hour sessions in a web-based group format.

Group Type ACTIVE_COMPARATOR

Low FODMAP Diet

Intervention Type OTHER

Subjects in the FODMAP group will be provided dietary instructions by a registered dietician during weekly 1-hour sessions in a web-based group format

Interventions

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Mindfulness-based Attention Training in IBS

The MB-IBS-EAT is an 8-week intervention with weekly 1-hour sessions in a web-based group format.

Intervention Type BEHAVIORAL

Low FODMAP Diet

Subjects in the FODMAP group will be provided dietary instructions by a registered dietician during weekly 1-hour sessions in a web-based group format

Intervention Type OTHER

Other Intervention Names

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Dietary Intervention

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No