← Back to Search

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 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

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,520 Previous Clinical Trials
503,170 Total Patients Enrolled
1 Trials studying Irritable Bowel Syndrome
175 Patients Enrolled for Irritable Bowel Syndrome
Louis LiuPrincipal InvestigatorUniversity Health Network, Toronto
~9 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top