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

Irritable Bowel Syndrome (IBS) Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05630703
• Other study ID #: IRB00083217
• Secondary ID: 07-19-15E
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Wake Forest University Health Sciences
• Contact: Jamie Crawford, RN, BSN
• Phone: 704-355-0282
• Email: jamie.crawford[@]atriumhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Irritable Bowel Syndrome (IBS)
• Syndrome

Intervention

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.

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

Locations

Country	Name	City	State
United States	Atrium Health Gastroenterology and Hepatology Morehead Medical Plaza	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in cortisol blood levels	differences in cortisol levels	Baseline and Week 8
Secondary	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
Secondary	Change in serotonin blood levels	differences in serotonin levels	Baseline and Week 8
Secondary	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
Secondary	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
Secondary	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
Secondary	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