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

N/ANot Yet RecruitingNCT05630703

Wake Forest University Health Sciences30 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Irritable Bowel Syndrome (IBS)

Interventions

Mindfulness-based Attention Training in IBSBEHAVIORAL

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

Low FODMAP DietOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Atrium Health Gastroenterology and Hepatology Morehead Medical Plaza

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

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"

Time frame: Baseline

Global Improvement Scale (GIS) Scores Week 1

Time frame: Week 1

Global Improvement Scale (GIS) Scores Week 4

Time frame: Week 4

Global Improvement Scale (GIS) Scores Week 8

Time frame: Week 8

Global Improvement Scale (GIS) Scores Week 12

Time frame: Week 12

Secondary Outcomes

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

Central Contacts

Jamie Crawford, RN, BSN

CONTACT

704-355-0282 jamie.crawford@atriumhealth.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: Baseline, Week 8, and Week 12

Change in cortisol blood levels

differences in cortisol levels

Time frame: 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

Time frame: Baseline and Week 8

Change in serotonin blood levels

differences in serotonin levels

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline, Week 1, Week 4, Week 8, and Week 12