Pilot Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- Harvard University Faculty of Medicine
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- IBS Global Improvement Scale
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Irritable bowel syndrome.
Exclusion Criteria
- •Any signs of organic bowel disease such as rectal bleeding.
- •No other major illnesses.
Outcomes
Primary Outcomes
IBS Global Improvement Scale
Time Frame: 3 weeks
Secondary Outcomes
- IBS Adequate Relief(3 weeks)
- IBS quality of life (QoL)(3 weeks)
- IBS Symptom Severity Scale(3 weeks)