NCT01010191

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

Pilot Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Harvard University Faculty of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	Sugar pill

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-11-09
• Last updated: 2011-06-22

Locations

1 site across 1 country: United States