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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

No Placebo-Only Group

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 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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out