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

NCT ID: NCT01010191

Last Updated: 2011-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cellulose pill

The active intervention is a sugar pill.

Group Type EXPERIMENTAL

Sugar pill

Intervention Type OTHER

No treatment

The control arm is wait list control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sugar pill

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Irritable bowel syndrome.

Exclusion Criteria

* Any signs of organic bowel disease such as rectal bleeding.
* No other major illnesses.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

Harvard University Faculty of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Harvard Medical School

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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. doi: 10.1371/journal.pone.0015591.

Reference Type DERIVED
PMID: 21203519 (View on PubMed)

Other Identifiers

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M16986

Identifier Type: -

Identifier Source: org_study_id

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