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

June 21, 2011 updated by: Harvard University Faculty of Medicine

Pilot Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Irritable bowel syndrome.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IBS Global Improvement Scale
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
IBS Adequate Relief
Time Frame: 3 weeks
3 weeks
IBS quality of life (QoL)
Time Frame: 3 weeks
3 weeks
IBS Symptom Severity Scale
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard University Faculty of Medicine

Collaborators

Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 6, 2009

First Posted (Estimate)

November 9, 2009

Study Record Updates

Last Update Posted (Estimate)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M16986

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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