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Effects of Open-label vs Double-blind Treatment in IBS

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ClinicalTrials.gov Identifier: NCT02802241
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Anthony Lembo, Beth Israel Deaconess Medical Center

Brief Summary:
The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Placebo Effect Placebos Peppermint Oil Drug: placebo Dietary Supplement: peppermint oil Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 307 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Effects of Open-label vs Double-blind Treatment in IBS
Study Start Date : June 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: open-label placebo Drug: placebo
Experimental: double-blind placebo Drug: placebo
Experimental: double-blind peppermint oil Dietary Supplement: peppermint oil
No Intervention: no additional treatment



Primary Outcome Measures :
  1. Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet Rome IV diagnostic criteria for IBS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802241


Contacts
Contact: Vivian Cheng IBS@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Vivian Cheng, MS, MPH    617-667-0682    vcheng2@bidmc.harvard.edu   
Sponsors and Collaborators
Anthony Lembo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anthony Lembo, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02802241     History of Changes
Other Study ID Numbers: 2015P000282
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Colonic Diseases, Functional
Irritable Bowel Syndrome
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peppermint oil
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Parasympatholytics