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Irritable Bowel Syndrome (IBS)FODMAPNCT05630703

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

A study testing Mindfulness-based Attention Training in IBS and Low FODMAP Diet in people with Irritable Bowel Syndrome (IBS), run by Wake Forest University Health Sciences.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Irritable Bowel Syndrome (IBS)
What is being tested?
Mindfulness-based Attention Training in IBS and Low FODMAP Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
May 2026to Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: 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

Read the 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.

Being tested
Mindfulness-based Attention Training in IBS, Low FODMAP Diet
Keywords
Irritable Bowel Syndrome (IBS), Mindfulness, FODMAP
Medical subject headings
Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-based Attention Training in IBSBehavioural

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

  • Low FODMAP DietOther

    Also called Dietary Intervention

    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

Study groups in NCT05630703
Study groupRoleWhat they receive
Mindfulness TrainingExperimentalBehavioral: 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.
Receives: Behavioral: Mindfulness-based Attention Training in IBS
fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) dietActive comparatorDietary: 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.
Receives: Other: Low FODMAP Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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"

    Measured: Baseline

  2. 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"

    Measured: Week 1

  3. 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"

    Measured: Week 4

  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"

    Measured: Week 8

  5. 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"

    Measured: Week 12

Secondary outcomes (11)

  1. 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

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

  2. 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

    Measured: Baseline, Week 4, Week 8, and Week 12

  3. 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

    Measured: Baseline, Week 8, and week 12

  4. 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)

    Measured: Baseline, Week 8, and Week 12

  5. Change in cortisol blood levels

    differences in cortisol levels

    Measured: Baseline and Week 8

  6. 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

    Measured: Baseline and Week 8

  7. Change in serotonin blood levels

    differences in serotonin levels

    Measured: Baseline and Week 8

  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.

    Measured: Baseline, Week 4, Week 8, and Week 12

  9. 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

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

  10. 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

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

  11. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2022
  2. Study startMay 2026 (estimated)
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Why it stopped: The study was withdrawn prior to initiation. No participants were enrolled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05630703
Sponsor's protocol ID
IRB00083217
Other IDs
07-19-15E
Acronym
FODMAP
Status last verified
Aug 2025
First submitted
15 Nov 2022
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-based Attention Training in IBS and Low FODMAP Diet in people with Irritable Bowel Syndrome (IBS), run by Wake Forest University Health Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Improvement Scale (GIS) Scores Baseline (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05630703.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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