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

Trial of Mindfulness-based Irritable Bowel Syndrome Eating Awareness Training as Compared to the Standard Low Fermentable Oligosaccharide, Disaccharide, Monosaccharide and Polyol Diet in Patients With Irritable Bowel Syndrome (IBS)

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

Study Overview

• Status: Withdrawn
• Conditions: Irritable Bowel Syndrome (IBS)
• Intervention / Treatment: Behavioral: Mindfulness-based Attention Training in IBS; Other: Low FODMAP Diet

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Atrium Health Gastroenterology and Hepatology Morehead Medical Plaza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	Other: 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 Names: Dietary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perceived Stress Level (PSS) Scores	Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress	Baseline, Week 1, Week 4, Week 8, and Week 12
Change in cortisol blood levels	differences in cortisol levels	Baseline and Week 8
Change in cytokine blood levels	differences in cytokine levels - cytokine levels drawn at 8 am at screening or baseline if patient agrees - The detection of intracellular cytokines is a relatively new technique in which cells are permeabilized and antibodies are used to detect cytokine protein within cells by flow cytometry - when too many cytokines are released, it can cause your immune system to go into overdrive	Baseline and Week 8
Change in serotonin blood levels	differences in serotonin levels	Baseline and Week 8
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Scores	The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life.	Baseline, Week 4, Week 8, and Week 12
Change in Hospital Anxiety and Depression Scale (HADS) Scores	The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression	Baseline, Week 1, Week 4, Week 8, and Week 12
Change in Irritable bowel syndrome symptom severity (IBS-SSS) Scores	IBS-SSS is a composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life (QoL). Each measure is rated from 0 to 100, with total scores ranging from 0 to 500 - Mild, moderate and severe cases were indicated by scores of 75 to 175, 175 to 300 and > 300	Baseline, Week 1, Week 4, Week 8, and Week 12
Gastroparesis Cardinal Symptom Index (GCSI) Scores	The GCSI total score is constructed as the average of the three symptom subscales. GCSI total score can range from 0 to 5, with higher scores reflecting greater symptom severity	Baseline, Week 1, Week 4, Week 8, and Week 12
Change in Five Factor Mindfulness Questionnaire (5FMQ) Scores	39-question measure that assesses trait mindfulness. In addition to the total score, there are five subscales: Non-judgement, Non-reaction, Describe, Observe, and Act with Awareness - Average scores are calculated by summing the responses and dividing by the number of items, and indicate the average level of agreement with the each subscale (1 = rarely true, 5 = always true). Higher scores are indicative of someone who is more mindful in their everyday life	Baseline, Week 4, Week 8, and Week 12
Change in Mindful Eating Questionnaire (MEQ) Scores	28-question measure that assesses eating habits and mental tendencies while eating - Scoring. Each item was scored from 1 to 4, where higher scores signified more mindful eating. Each subscale score was calculated as the mean of items, excluding those with a "not-applicable" response. The summary score was the mean of the 5 subscales	Baseline, Week 8, and week 12
Change in Positive and Negative Affect Schedule (PANAS_State) Questionnaire Scores	20-question measure that assesses the degree to which positive and negative emotions are currently being felt - Positive Affect Score: Add the scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can range from 10 - 50, with higher scores representing higher levels of positive affect - Mean Scores: 33.3 (SD±7.2) Negative Affect Score: Add the scores on items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20. Scores can range from 10 - 50, with lower scores representing lower levels of negative affect - Mean Score: 17.4 (SD ± 6.2)	Baseline, Week 8, and Week 12

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Baharak Moshiree, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 25, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Mindfulness; Irritable Bowel Syndrome (IBS); FODMAP
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Nutrition Therapy; Diet; Elimination Diets; FODMAP Diet; Diet Therapy
• Other Study ID Numbers: IRB00083217; 07-19-15E (Other Identifier: Atrium Health)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No