Effects of Open-label vs Double-blind Treatment in IBS
2 other identifiers
interventional
340
1 country
1
Brief Summary
The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 14, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedResults Posted
Study results publicly available
September 4, 2020
CompletedJanuary 22, 2024
January 1, 2024
2.6 years
June 14, 2016
July 20, 2020
January 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 weeks
Study Arms (4)
open-label placebo
EXPERIMENTALdouble-blind placebo
EXPERIMENTALdouble-blind peppermint oil
EXPERIMENTALno additional treatment
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Meet Rome IV diagnostic criteria for IBS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (2)
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.
PMID: 33605656DERIVEDBallou 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.
PMID: 28545508DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Judy Nee
- Organization
- BIDMC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
June 14, 2016
First Posted
June 16, 2016
Study Start
June 1, 2016
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
January 22, 2024
Results First Posted
September 4, 2020
Record last verified: 2024-01