Status:
COMPLETED
Acupuncture for Irritable Bowel Syndrome (IBS)
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether acupuncture is effective in reducing the symptoms of irritable bowel syndrome (IBS).
Detailed Description
IBS is a disorder that affects colon functioning. Although it does not cause permanent harm or lead to more serious conditions, IBS can cause a great deal of discomfort and distress. The effectiveness...
Eligibility Criteria
Inclusion
- Irritable bowel syndrome of moderate severity for at least 12 weeks within 1 year prior to study entry
- Colonoscopy or flexible sigmoidoscopy/air contrast barium enema within 5 years prior to study entry
- Able to walk
- Able and willing to cooperate with the study
- Sufficient knowledge of English to be able to participate in the study
Exclusion
- Medications that affect the gastrointestinal tract or visceral sensation, unless the participant is on a stable dose for at least 1 month prior to study entry and for the duration of the study
- History of severe or intractable IBS
- History of acupuncture treatment
- Score between 37 and 150 on the Functional Bowel Disorder Severity Index (FBDSI)
- Any concomitant bowel problem that would interfere with the study
- History of laxative abuse
- Abdominal surgery, with the exception of uncomplicated removal of the appendix, uterus, or gallbladder more than 6 months prior to study entry
- History of metabolic or inflammatory disease that may affect bowel movement
- History of significant psychiatric, neurological, metabolic, hepatic, renal, infectious, hematological, cardiovascular, gastrointestinal, or pulmonary illness. Participants who are stable for more than 1 year with conditions that will not interfere with the study are not excluded.
- History of drug or alcohol abuse within 2 years prior to study entry
- Positive for opiates at the initial visit drug screen
- Abnormal vital signs, physical examination results, or clinical laboratory values, unless these abnormalities are judged to be clinically insignificant
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT00093327
Start Date
September 1 2003
End Date
April 1 2006
Last Update
August 18 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center, General Clinical Research Center
Boston, Massachusetts, United States, 02215