Back to resultsEffects of Open-label vs Double-blind Treatment in IBS
Primary Purpose
Irritable Bowel Syndrome, Placebo Effect, Placebos
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
placebo
peppermint oil
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- Meet Rome IV diagnostic criteria for IBS
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
open-label placebo
double-blind placebo
double-blind peppermint oil
no additional treatment
Arm Description
Outcomes
Primary Outcome Measures
Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks.
Score ranges from 0-500, 0 indicates no symptoms, 500 indicates worst possible symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT02802241
First Posted
June 14, 2016
Last Updated
September 3, 2020
Sponsor
Anthony Lembo
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT02802241
Brief Title
Effects of Open-label vs Double-blind Treatment in IBS
Official Title
Effects of Open-label vs Double-blind Treatment in IBS.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anthony Lembo
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Placebo Effect, Placebos, Peppermint Oil
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
340 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open-label placebo
Arm Type
Experimental
Arm Title
double-blind placebo
Arm Type
Experimental
Arm Title
double-blind peppermint oil
Arm Type
Experimental
Arm Title
no additional treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
peppermint oil
Primary Outcome Measure Information:
Title
Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks.
Description
Score ranges from 0-500, 0 indicates no symptoms, 500 indicates worst possible symptoms
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet Rome IV diagnostic criteria for IBS
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33605656
Citation
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.
Results Reference
derived
PubMed Identifier
28545508
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Open-label vs Double-blind Treatment in IBS
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