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Harnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01010191
Recruitment Status : Completed
First Posted : November 9, 2009
Last Update Posted : June 22, 2011
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by:
Harvard University Faculty of Medicine

Study Description
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Brief Summary:
Irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Other: Sugar pill Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Randomized Controlled Trial
Study Start Date : July 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cellulose pill
The active intervention is a sugar pill.
 Other: Sugar pill
No Intervention: No treatment
The control arm is wait list control


Outcome Measures
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Primary Outcome Measures :
  1. IBS Global Improvement Scale [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. IBS Adequate Relief [ Time Frame: 3 weeks ]
  2. IBS quality of life (QoL) [ Time Frame: 3 weeks ]
  3. IBS Symptom Severity Scale [ Time Frame: 3 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Irritable bowel syndrome.

Exclusion Criteria:

  • Any signs of organic bowel disease such as rectal bleeding.
  • No other major illnesses.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010191


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Harvard University Faculty of Medicine
Beth Israel Deaconess Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ted Kaptchuk, Harvard Medical School
ClinicalTrials.gov Identifier: NCT01010191    
Other Study ID Numbers: M16986
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011
Keywords provided by Harvard University Faculty of Medicine:
irritable bowel syndrome
no organic digestive disease
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases