Back to resultsMindfulness Training Versus Low (FODMAP) Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols Diet (FODMAP)
Primary Purpose
Irritable Bowel Syndrome (IBS)
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based Attention Training in IBS
Low FODMAP Diet
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome (IBS) focused on measuring Irritable Bowel Syndrome (IBS), Mindfulness, FODMAP
Eligibility Criteria
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
Sites / Locations
- Atrium Health Gastroenterology and Hepatology Morehead Medical Plaza
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness Training
fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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"
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"
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"
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"
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"
Secondary Outcome Measures
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
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
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
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)
Change in cortisol blood levels
differences in cortisol levels
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
Change in serotonin blood levels
differences in serotonin levels
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.
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
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
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
Full Information
NCT ID
NCT05630703
First Posted
November 15, 2022
Last Updated
June 27, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05630703
Brief Title
Mindfulness Training Versus Low (FODMAP) Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols Diet
Acronym
FODMAP
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome (IBS)
Keywords
Irritable Bowel Syndrome (IBS), Mindfulness, FODMAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Training
Arm Type
Experimental
Arm Description
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.
Arm Title
fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Attention Training in IBS
Intervention Description
The MB-IBS-EAT is an 8-week intervention with weekly 1-hour sessions in a web-based group format.
Intervention Type
Other
Intervention Name(s)
Low FODMAP Diet
Other Intervention Name(s)
Dietary Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Global Improvement Scale (GIS) Scores Baseline
Description
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
Title
Global Improvement Scale (GIS) Scores Week 1
Description
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
Week 1
Title
Global Improvement Scale (GIS) Scores Week 4
Description
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
Week 4
Title
Global Improvement Scale (GIS) Scores Week 8
Description
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
Week 8
Title
Global Improvement Scale (GIS) Scores Week 12
Description
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
Week 12
Secondary Outcome Measure Information:
Title
Change in Perceived Stress Level (PSS) Scores
Description
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
Time Frame
Baseline, Week 1, Week 4, Week 8, and Week 12
Title
Change in Five Factor Mindfulness Questionnaire (5FMQ) Scores
Description
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
Title
Change in Mindful Eating Questionnaire (MEQ) Scores
Description
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
Title
Change in Positive and Negative Affect Schedule (PANAS_State) Questionnaire Scores
Description
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
Title
Change in cortisol blood levels
Description
differences in cortisol levels
Time Frame
Baseline and Week 8
Title
Change in cytokine blood levels
Description
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
Title
Change in serotonin blood levels
Description
differences in serotonin levels
Time Frame
Baseline and Week 8
Title
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Scores
Description
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
Title
Change in Hospital Anxiety and Depression Scale (HADS) Scores
Description
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
Title
Change in Irritable bowel syndrome symptom severity (IBS-SSS) Scores
Description
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
Title
Gastroparesis Cardinal Symptom Index (GCSI) Scores
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Crawford, RN, BSN
Phone
704-355-0282
Email
jamie.crawford@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baharak Moshiree, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health Gastroenterology and Hepatology Morehead Medical Plaza
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Crawford, RN, BSN
Phone
704-355-0282
Email
jamie.crawford@atriumhealth.org
12. IPD Sharing Statement
Learn more about this trial
Mindfulness Training Versus Low (FODMAP) Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols Diet
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