Irritable Bowel SyndromePhase 2NCT00093327
Acupuncture for Irritable Bowel Syndrome (IBS)
A Phase 2 study testing Acupuncture in people with Irritable Bowel Syndrome, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether acupuncture is effective in reducing the symptoms of irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 287 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center, General Clinical Research Center
Boston, Massachusetts, 02215
About this study
Official title: Acupuncture for Irritable Bowel Syndrome (IBS) Trial
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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Acupuncture
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2004 (estimated)
- Study startSep 2003
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 287 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Ted Kaptchuk, OMD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093327
- Sponsor's protocol ID
- R01AT001414-01
- Status last verified
- Aug 2006
- First submitted
- 6 Oct 2004
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Irritable Bowel Syndrome (IBS) Trial
- ClinicalTrials.gov ID
- NCT00093327
- Acronym / sponsor ID
- R01AT001414-01
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2003
- Study completion
- Apr 2006
- First posted
- 8 Oct 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
Related trials for Irritable Bowel Syndrome
Recruiting
IBS Skin Patch Test Food Allergy Study
Irritable Bowel Syndrome
Enrolling by invitationPhase 2
Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Not yet recruiting
Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
Irritable Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ted Kaptchuk, OMD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture in people with Irritable Bowel Syndrome, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2006.