Acupuncture for Irritable Bowel Syndrome (IBS)

NCT00093327 | Completed Phase 2

• 1 other identifier: R01AT001414-01
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether acupuncture is effective in reducing the symptoms of irritable bowel syndrome (IBS).

Conditions

Irritable Bowel Syndrome

Interventions

Acupuncture PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center, General Clinical Research Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ted Kaptchuk, OMD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 6, 2004
• First Posted: October 8, 2004
• Study Start: September 1, 2003
• Study Completion: April 1, 2006
• Last Updated: August 18, 2006

Record last verified: 2006-08

Locations

US (1)