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Acupuncture for Irritable Bowel Syndrome (IBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center, General Clinical Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 6, 2004
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00093327
Brief Title
Acupuncture for Irritable Bowel Syndrome (IBS)
Official Title
Acupuncture for Irritable Bowel Syndrome (IBS) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

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 of acupuncture in treating various conditions has been investigated in numerous studies. However, little is known about acupuncture's efficacy in treating IBS. This study will determine whether acupuncture can alleviate the symptoms of IBS, including pain relief with defecation, changes in stools, and changes in the frequency of bowel movements. Participants in this study will be randomly assigned to receive bi-weekly sessions of either active or placebo acupuncture or no treatment for 6 weeks. Study visits will occur at study start, Week 3, and Week 6 (study completion). At each study visit, blood collection will occur to measure levels of cortisol, a stress hormone associated with IBS. Participants will also complete questionnaires about their IBS symptoms. Selected participants will be interviewed at each visit, in order to determine whether participants' interpretations and understanding of IBS influences their response to treatment. Any subject who does not receive active acupuncture during the trial is eligible for 6 free acupuncture treatments after the study is over.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
287 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Acupuncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ted Kaptchuk, OMD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center, General Clinical Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Acupuncture for Irritable Bowel Syndrome (IBS)

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