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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

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, week 4, week 8, and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 4, week 8, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Global Improvement Scale (GIS) Scores Baseline
Global Improvement Scale (GIS) Scores Week 1
Global Improvement Scale (GIS) Scores Week 12
+2 more
Secondary study objectives
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 more

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.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,677 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

Media Library

Low FODMAP Diet Clinical Trial Eligibility Overview. Trial Name: NCT05630703 — N/A
Irritable Bowel Syndrome Research Study Groups: Mindfulness Training, fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet
Irritable Bowel Syndrome Clinical Trial 2023: Low FODMAP Diet Highlights & Side Effects. Trial Name: NCT05630703 — N/A
Low FODMAP Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630703 — N/A
~20 spots leftby Apr 2025
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