Clinical trial NCT05630703: Mindfulness Training Versus Low (FODMAP) Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols Diet
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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome (IBS)
Keywords: Irritable Bowel Syndrome (IBS)
Mindfulness
FODMAP
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Global Improvement Scale (GIS) Scores Baseline
timeFrame: Baseline
measure: Global Improvement Scale (GIS) Scores Week 1
timeFrame: Week 1
measure: Global Improvement Scale (GIS) Scores Week 4
timeFrame: Week 4
measure: Global Improvement Scale (GIS) Scores Week 8
timeFrame: Week 8
measure: Global Improvement Scale (GIS) Scores Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change in Perceived Stress Level (PSS) Scores
timeFrame: Baseline, Week 1, Week 4, Week 8, and Week 12
measure: Change in Five Factor Mindfulness Questionnaire (5FMQ) Scores
timeFrame: Baseline, Week 4, Week 8, and Week 12
measure: Change in Mindful Eating Questionnaire (MEQ) Scores
timeFrame: Baseline, Week 8, and week 12
measure: Change in Positive and Negative Affect Schedule (PANAS_State) Questionnaire Scores
timeFrame: Baseline, Week 8, and Week 12
measure: Change in cortisol blood levels
timeFrame: Baseline and Week 8
measure: Change in cytokine blood levels
timeFrame: Baseline and Week 8
measure: Change in serotonin blood levels
timeFrame: Baseline and Week 8
measure: Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Scores
timeFrame: Baseline, Week 4, Week 8, and Week 12
measure: Change in Hospital Anxiety and Depression Scale (HADS) Scores
timeFrame: Baseline, Week 1, Week 4, Week 8, and Week 12
measure: Change in Irritable bowel syndrome symptom severity (IBS-SSS) Scores
timeFrame: Baseline, Week 1, Week 4, Week 8, and Week 12
measure: Gastroparesis Cardinal Symptom Index (GCSI) Scores
timeFrame: Baseline, Week 1, Week 4, Week 8, and Week 12
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health Gastroenterology and Hepatology Morehead Medical Plaza
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Baharak Moshiree, MD
role: PRINCIPAL_INVESTIGATOR
References: