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

NCT05630703 | Withdrawn

• 2 other identifiers: IRB0008321707-19-15E
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Irritable Bowel Syndrome (IBS); Mindfulness; FODMAP

Outcome Measures

Primary Outcomes (5)

• Global Improvement Scale (GIS) Scores Baseline

  The Global Improvement Scale is an overall assessment of Irritable Bowel Syndrome (IBS) symptoms using a patient-defined 7-point Likert scale ranging from "substantially worse" to "substantially improved"

  Baseline

• Global Improvement Scale (GIS) Scores Week 1

  The Global Improvement Scale is an overall assessment of Irritable Bowel Syndrome (IBS) symptoms using a patient-defined 7-point Likert scale ranging from "substantially worse" to "substantially improved"

  Week 1

• Global Improvement Scale (GIS) Scores Week 4

  The Global Improvement Scale is an overall assessment of Irritable Bowel Syndrome (IBS) symptoms using a patient-defined 7-point Likert scale ranging from "substantially worse" to "substantially improved"

  Week 4

• Global Improvement Scale (GIS) Scores Week 8

  The Global Improvement Scale is an overall assessment of Irritable Bowel Syndrome (IBS) symptoms using a patient-defined 7-point Likert scale ranging from "substantially worse" to "substantially improved"

  Week 8

• Global Improvement Scale (GIS) Scores Week 12

  The Global Improvement Scale is an overall assessment of Irritable Bowel Syndrome (IBS) symptoms using a patient-defined 7-point Likert scale ranging from "substantially worse" to "substantially improved"

  Week 12

Secondary Outcomes (11)

• Change in Perceived Stress Level (PSS) Scores

  Baseline, Week 1, Week 4, Week 8, and Week 12

• Change in Five Factor Mindfulness Questionnaire (5FMQ) Scores

  Baseline, Week 4, Week 8, and Week 12

• Change in Mindful Eating Questionnaire (MEQ) Scores

  Baseline, Week 8, and week 12

• Change in Positive and Negative Affect Schedule (PANAS_State) Questionnaire Scores

  Baseline, Week 8, and Week 12

• Change in cortisol blood levels

  Baseline and Week 8

Study Arms (2)

Mindfulness Training

EXPERIMENTAL

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.

Behavioral: Mindfulness-based Attention Training in IBS

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

ACTIVE COMPARATOR

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.

Other: Low FODMAP Diet

Interventions

Mindfulness-based Attention Training in IBS BEHAVIORAL

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

Mindfulness Training

Low FODMAP Diet 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

Also known as: Dietary Intervention

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet; Diet Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Baharak Moshiree, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 30, 2022
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2025-08

Locations

US (1)