Acupuncture for Irritable Bowel Syndrome (IBS)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00093327
• Date of registration: 06/10/2004
• Prospective Registration: No
• Primary sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Public title: Acupuncture for Irritable Bowel Syndrome (IBS)
• Scientific title: Acupuncture for Irritable Bowel Syndrome (IBS) Trial
• Date of first enrolment: September 2003
• Target sample size: 287
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00093327
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Ted Kaptchuk, OMD
• Affiliation: Beth Israel Deaconess Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome

Intervention(s)

Procedure: Acupuncture

Secondary ID(s)

R01 AT001414-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)