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

This study has been completed.
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by:
Harvard University Faculty of Medicine
ClinicalTrials.gov Identifier:
NCT01010191
First received: November 5, 2009
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention
Irritable Bowel Syndrome
Other: Sugar pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Randomized Controlled Trial

Further study details as provided by Harvard University Faculty of Medicine:

Primary Outcome Measures:
  • IBS Global Improvement Scale [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IBS Adequate Relief [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • IBS quality of life (QoL) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • IBS Symptom Severity Scale [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cellulose pill
The active intervention is a sugar pill.
Other: Sugar pill
No Intervention: No treatment
The control arm is wait list control

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01010191

Locations
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

No publications provided by Harvard University Faculty of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ted Kaptchuk, Harvard Medical School
ClinicalTrials.gov Identifier: NCT01010191     History of Changes
Other Study ID Numbers: M16986
Study First Received: November 5, 2009
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Harvard University Faculty of Medicine:
irritable bowel syndrome
no organic digestive disease

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014