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Completed

NCT Number: NCT01010191

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

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

Completed

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Irritable bowel syndrome.

Exclusion criteria

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

Treatment and study plan

Sugar Pill

Other

Primary outcomes

  1. IBS Global Improvement Scale

    Time frame: 3 weeks

Secondary outcomes

  1. IBS Adequate Relief

    Time frame: 3 weeks

  2. IBS quality of life (QoL)

    Time frame: 3 weeks

  3. IBS Symptom Severity Scale

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Harvard University Faculty of Medicine

Other

Collaborators

  • Beth Israel Deaconess Medical Center

Registry information

Official study title

Pilot Randomized Controlled Trial

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 9, 2009
Registry last updated
Jun 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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