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Gut-directed Hypnotherapy for IBS in Ehlers-Danlos Syndrome

N/A

Waitlist Available

Led By Louis Liu

Research Sponsored by University Health Network, Toronto

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 immediately post-treatment, 3-months post-treatment

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test if gut-directed hypnotherapy can help manage Irritable Bowel Syndrome (IBS) in individuals with Ehlers-Danlos Syndromes or Generalized Hypermobility

Who is the study for?

This trial is for individuals with Ehlers-Danlos Syndromes or Generalized Hypermobility Spectrum Disorders who also have Irritable Bowel Syndrome. They must be on a stable IBS medication dose for 4 weeks before joining and able to understand English well. People with certain bowel diseases, major gut surgery history, serious mental illness, cognitive issues, or heavy alcohol use cannot participate.

What is being tested?

The study tests if gut-directed hypnotherapy plus standard medical therapy improves IBS symptoms in patients with EDS/G-HSD compared to standard therapy alone. Participants will either receive regular doctor visits or the same visits plus eight sessions of hypnotherapy aimed at relaxing the gut and improving its function.

What are the potential side effects?

Gut-directed hypnotherapy is generally considered safe but may cause temporary discomfort like headache or dizziness right after treatment. It's non-invasive so it doesn't have typical drug side effects; however, emotional distress due to relaxation techniques could occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately post-treatment, 3-months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately post-treatment, 3-months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately post-treatment, 3-months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

IBS Symptom Severity

Secondary study objectives

Emotional Distress

IBS-related Quality of Life

Upper Gastrointestinal Symptoms

+1 more

Other study objectives

Weekly Ratings of GI Health and Medication Use

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

Group I: Standard Medical Therapy plus Gut-Directed HypnotherapyExperimental Treatment2 Interventions

In addition to Standard Medical Therapy, participants randomized to this arm will attend 8 sessions of gut-directed hypnotherapy by a trained behavioral therapist. The treatment protocol developed for the proposed study was adapted from the empirically-supported Manchester Protocol for gut-directed hypnotherapy. At each visit, a voluntary, pleasant, and dream-like state of deep relaxation will be induced and suggestions made for greater relaxation, abdominal comfort, and normalization of gut function. The first session will be 90 minutes in duration and the remaining sessions will be 60 minutes. At the first session, participants will be provided with 30 minutes of education on the nature of the gut-brain axis and hypnotherapy before they undergo hypnotherapy.

Group II: Standard Medical TherapyExperimental Treatment1 Intervention

Standard Medical Treatment will be administered by board certified gastroenterologists through the EDS Clinic gastroenterology clinical care pathway. Therapies will be individualized to the participants' current symptoms and severity of symptoms as per current clinical guidelines for management of IBS. Potential therapies that may be administered include dietary changes, supplemental fibre, and pharmacotherapy (including neuromodulators) as appropriate.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gut-directed hypnotherapy

2014

N/A

~350

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