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CompletedNCT00093327Updated Aug 18, 2006

Acupuncture for Irritable Bowel Syndrome (IBS)

A Phase 2 interventional study of Acupuncture in Irritable Bowel Syndrome, sponsored by National Center for Complementary and Integrative Health (NCCIH). Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2006-08-18.

Sponsored by National Center for Complementary and Integrative Health (NCCIH) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
287
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Irritable Bowel Syndrome
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 287 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH) is the lead sponsor of 218 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
287 participants

Interventions

  • ProcedureAcupuncture
06

Study locations

1 site
  • Beth Israel Deaconess Medical Center, General Clinical Research Center
    Boston, Massachusetts 02215, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00093327
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted
Oct 8, 2004
Start date
Sep 2003
Completion
Apr 2006
Last update
Aug 18, 2006

Study contacts

Ted Kaptchuk, OMD
principal investigator · Beth Israel Deaconess Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

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