Irritable Bowel SyndromeNCT02802241
Effects of Open-label vs Double-blind Treatment in IBS
A study testing peppermint oil in people with Irritable Bowel Syndrome and Placebo Effect, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Placebo Effect, Placebos
- What is being tested?
- peppermint oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet Rome IV diagnostic criteria for IBS
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Effects of Open-label vs Double-blind Treatment in IBS.
The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.
- Conditions
- Irritable Bowel Syndrome, Placebo Effect, Placebos, Peppermint Oil
- Being tested
- placebo, peppermint oil
- 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.
placeboDrug
peppermint oilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| open-label placebo | Experimental | Not described Receives: Drug: placebo |
| double-blind placebo | Experimental | Not described Receives: Drug: placebo |
| double-blind peppermint oil | Experimental | Not described Receives: Dietary Supplement: peppermint oil |
| no additional treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks.
Score ranges from 0-500, 0 indicates no symptoms, 500 indicates worst possible symptoms
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Judy Nee, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802241
- Sponsor's protocol ID
- 2015P000282
- Other IDs
- R01AT008573
- Status last verified
- Jan 2024
- First submitted
- 14 Jun 2016
- Last updated
- 22 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Lembo A, Kelley JM, Nee J, Ballou S, Iturrino J, Cheng V, Rangan V, Katon J, Hirsch W, Kirsch I, Hall K, Davis RB, Kaptchuk TJ. Open-label placebo vs double-blind placebo for irritable bowel syndrome: a randomized clinical trial. Pain. 2021 Sep 1;162(9):2428-2435. doi: 10.1097/j.pain.0000000000002234.
PubMed 33605656Ballou S, Kaptchuk TJ, Hirsch W, Nee J, Iturrino J, Hall KT, Kelley JM, Cheng V, Kirsch I, Jacobson E, Conboy L, Lembo A, Davis RB. Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial. Trials. 2017 May 25;18(1):234. doi: 10.1186/s13063-017-1964-x.
PubMed 28545508
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Open-label vs Double-blind Treatment in IBS.
- ClinicalTrials.gov ID
- NCT02802241
- Acronym / sponsor ID
- 2015P000282
- Conditions
- Irritable Bowel Syndrome, Placebo Effect, Placebos, Peppermint Oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jun 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Posted 4 Sep 2020
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 investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| open-label placebo | Experimental | Drug: placebo |
| double-blind placebo | Experimental | Drug: placebo |
| double-blind peppermint oil | Experimental | Dietary Supplement: peppermint oil |
| no additional treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meet Rome IV diagnostic criteria for IBS
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| placebo | Drug | double-blind placebo, open-label placebo |
| peppermint oil | Dietary supplement | double-blind peppermint oil |
Primary outcome
Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks.
Time frame: 6 weeks
Score ranges from 0-500, 0 indicates no symptoms, 500 indicates worst possible symptoms
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33605656Lembo A, Kelley JM, Nee J, Ballou S, Iturrino J, Cheng V, Rangan V, Katon J, Hirsch W, Kirsch I, Hall K, Davis RB, Kaptchuk TJ. Open-label placebo vs double-blind placebo for irritable bowel syndrome: a randomized clinical trial. Pain. 2021 Sep 1;162(9):2428-2435. doi: 10.1097/j.pain.0000000000002234.
- Derived from this study: PubMed 28545508Ballou S, Kaptchuk TJ, Hirsch W, Nee J, Iturrino J, Hall KT, Kelley JM, Cheng V, Kirsch I, Jacobson E, Conboy L, Lembo A, Davis RB. Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial. Trials. 2017 May 25;18(1):234. doi: 10.1186/s13063-017-1964-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peppermint oil in people with Irritable Bowel Syndrome and Placebo Effect, run by Beth Israel Deaconess Medical Center 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 1 inclusion and 0 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 22 Jan 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02802241, which also lists 2 linked publications.
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 22 Jan 2024.