Back to resultsHarnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sugar pill
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring irritable bowel syndrome, no organic digestive disease
Eligibility Criteria
Inclusion Criteria:
- Irritable bowel syndrome.
Exclusion Criteria:
- Any signs of organic bowel disease such as rectal bleeding.
- No other major illnesses.
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cellulose pill
No treatment
Arm Description
The active intervention is a sugar pill.
The control arm is wait list control
Outcomes
Primary Outcome Measures
IBS Global Improvement Scale
Secondary Outcome Measures
IBS Adequate Relief
IBS quality of life (QoL)
IBS Symptom Severity Scale
Full Information
NCT ID
NCT01010191
First Posted
November 5, 2009
Last Updated
June 21, 2011
Sponsor
Harvard University Faculty of Medicine
Collaborators
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01010191
Brief Title
Harnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)
Official Title
Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Harvard University Faculty of Medicine
Collaborators
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.
Detailed Description
Seventy patients with irritable bowel syndrome (IBS) will be randomized to either 1) placebo pill or 2) no treatment and followed for 3 weeks. The study will involve three visits: baseline, midpoint and end point. At baseline all patients will physical examination, be evaluated for IBS and be administered standardized IBS questionnaires including: "IBS adequate relief" questionnaire, IBS global symptom improvement scale, IBS quality of life and IBS symptom severity scale. At midpoint and endpoint the same questionnaires will be administered. Patients on no treatment will be offered education on managing IBS at the end of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
irritable bowel syndrome, no organic digestive disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cellulose pill
Arm Type
Experimental
Arm Description
The active intervention is a sugar pill.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
The control arm is wait list control
Intervention Type
Other
Intervention Name(s)
Sugar pill
Primary Outcome Measure Information:
Title
IBS Global Improvement Scale
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
IBS Adequate Relief
Time Frame
3 weeks
Title
IBS quality of life (QoL)
Time Frame
3 weeks
Title
IBS Symptom Severity Scale
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Irritable bowel syndrome.
Exclusion Criteria:
Any signs of organic bowel disease such as rectal bleeding.
No other major illnesses.
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21203519
Citation
Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.
Results Reference
derived
Learn more about this trial
Harnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)
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