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

This study has been completed.

First Received on November 5, 2009. Last Updated on June 21, 2011 History of Changes

Sponsor:	Harvard University Faculty of Medicine
Collaborator:	Beth Israel Deaconess Medical Center
Information provided by:	Harvard University Faculty of Medicine
ClinicalTrials.gov Identifier:	NCT01010191

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

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):

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.

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:

Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases

Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 24, 2012