Irritable Bowel Syndrome
Conditions
Keywords
irritable bowel syndrome, no organic digestive disease
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.
Interventions
OTHERSugar pill
Sponsors
Beth Israel Deaconess Medical Center
Harvard University Faculty of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Irritable bowel syndrome.
Exclusion criteria
* Any signs of organic bowel disease such as rectal bleeding. * No other major illnesses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IBS Global Improvement Scale | 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| IBS Adequate Relief | 3 weeks |
| IBS quality of life (QoL) | 3 weeks |
| IBS Symptom Severity Scale | 3 weeks |
Countries
United States
Outcome results
None listed