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

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT01010191
• Lead Sponsor: Harvard University Faculty of Medicine

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-06
• Study First Posted: 2009-11-09
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Irritable bowel syndrome.

Exclusion Criteria

• Any signs of organic bowel disease such as rectal bleeding.
• No other major illnesses.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
IBS Global Improvement Scale	3 weeks

Secondary Outcome Measures

Name	Time	Method
IBS Adequate Relief	3 weeks
IBS quality of life (QoL)	3 weeks
IBS Symptom Severity Scale	3 weeks

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States