Effects of Open-label vs Double-blind Treatment in IBS
January 17, 2024 updated by: Judy Nee, Beth Israel Deaconess Medical Center
Effects of Open-label vs Double-blind Treatment in IBS.
The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
340
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Meet Rome IV diagnostic criteria for IBS
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: open-label placebo
|
|
|
Experimental: double-blind placebo
|
|
|
Experimental: double-blind peppermint oil
|
|
|
No Intervention: no additional treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks.
Time Frame: 6 weeks
|
Score ranges from 0-500, 0 indicates no symptoms, 500 indicates worst possible symptoms
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lembo A, Kelley JM, Nee J, Ballou S, Iturrino J, Cheng V, Rangan V, Katon J, Hirsch W, Kirsch I, Hall K, Davis RB, Kaptchuk TJ. Open-label placebo vs double-blind placebo for irritable bowel syndrome: a randomized clinical trial. Pain. 2021 Sep 1;162(9):2428-2435. doi: 10.1097/j.pain.0000000000002234.
- Ballou S, Kaptchuk TJ, Hirsch W, Nee J, Iturrino J, Hall KT, Kelley JM, Cheng V, Kirsch I, Jacobson E, Conboy L, Lembo A, Davis RB. Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial. Trials. 2017 May 25;18(1):234. doi: 10.1186/s13063-017-1964-x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
January 1, 2019
Study Completion (Actual)
January 1, 2019
Study Registration Dates
First Submitted
June 14, 2016
First Submitted That Met QC Criteria
June 14, 2016
First Posted (Estimated)
June 16, 2016
Study Record Updates
Last Update Posted (Actual)
January 22, 2024
Last Update Submitted That Met QC Criteria
January 17, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015P000282
- R01AT008573 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.