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Mindfulness Training vs. Low FODMAP Diet for Irritable Bowel Syndrome (FODMAP Trial)
N/A
Waitlist Available
Led By Baharak Moshiree, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, week 4, week 8, and week 12
Awards & highlights
FODMAP Trial Summary
This trial compares a mindfulness-based approach to treating IBS to a diet-based one, to see which helps symptoms more.
Who is the study for?
This trial is for adults over 18 with Irritable Bowel Syndrome (IBS) who can access the internet and understand consent forms. It's not for those already on a low FODMAP diet, with certain psychiatric conditions (excluding depression/anxiety), cancer in the last 5 years, eating disorders, pregnant women, or substance abuse history.Check my eligibility
What is being tested?
The study compares mindfulness-based attention training specifically designed for IBS against a low FODMAP diet to see which better alleviates IBS symptoms. Participants will either learn mindfulness techniques or follow a strict dietary plan.See study design
What are the potential side effects?
Mindfulness training may cause temporary discomfort like increased awareness of symptoms or frustration. The low FODMAP diet could lead to nutritional deficiencies if not properly managed.
FODMAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 1, week 4, week 8, and week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, week 4, week 8, and week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Global Improvement Scale (GIS) Scores Baseline
Global Improvement Scale (GIS) Scores Week 1
Global Improvement Scale (GIS) Scores Week 12
+2 moreSecondary outcome measures
Change in Five Factor Mindfulness Questionnaire (5FMQ) Scores
Change in Hospital Anxiety and Depression Scale (HADS) Scores
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Scores
+8 moreFODMAP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness TrainingExperimental Treatment1 Intervention
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.
Group II: fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) dietActive Control1 Intervention
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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,207 Total Patients Enrolled
1 Trials studying Irritable Bowel Syndrome
10 Patients Enrolled for Irritable Bowel Syndrome
Baharak Moshiree, MDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
428 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have been practicing yoga or mindfulness therapy in the last 3 months.I have had cancer in the last 5 years.I experience nausea or vomiting.I have been diagnosed with IBS according to Rome IV criteria.I can legally and mentally understand and sign a consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness Training
- Group 2: fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still capacity for enrolment in this research project?
"Sadly, this particular trial is no longer recruiting. It was initially posted on January 1st 2023 and had its last update on November 25th 2022. However, 1428 other trials are actively searching for volunteers at the moment."
Answered by AI
What are the desired outcomes of this inquiry?
"The primary endpoint of this trial, assessed over a 12-week period, is the Global Improvement Scale (GIS) Scores at Week 8. Secondary outcomes include Change in Mindful Eating Questionnaire (MEQ) Scores - a 28-question survey that evaluates dietary practices and psychological tendencies while eating; differences in serotonin levels; as well as Perceived Stress Level (PSS) Scores which range from 0 to 40 with higher scores indicating greater perceived stress: low being 0-13, moderate 14-26, high 27-40."
Answered by AI
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