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Standard Medical Therapy for Irritable Bowel 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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
IBS Symptom Severity
Secondary outcome measures
Emotional Distress
IBS-related Quality of Life
Upper Gastrointestinal Symptoms
+1 moreOther outcome measures
Weekly Ratings of GI Health and Medication Use
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
1,476 Previous Clinical Trials
485,106 Total Patients Enrolled
Louis LiuPrincipal InvestigatorUniversity Health Network, Toronto
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any ongoing efforts to enroll patients in this clinical trial at the moment?
"As per clinicaltrials.gov, this particular investigation is not currently seeking volunteers. Its initial posting date was April 1st, 2024, with the most recent update on March 15th, 2024. Nevertheless, there are a substantial number of 1538 ongoing trials actively enrolling participants at present."
Answered by AI
What are the criteria for eligibility to enroll in this medical study?
"To qualify for participation in this research, individuals must have a diagnosis of irritable bowel syndrome and be between 18 and 80 years old. This study aims to enroll approximately 74 eligible candidates."
Answered by AI
Is the inclusion criterion for this study set at a minimum age of 18 years?
"Individuals aged between 18 and 80 are sought for participation in this study. Notably, there are a total of 387 investigations focused on individuals under 18 years old and 1096 studies targeting those over the age of 65."
Answered by AI
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