We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Simethicone and Bowel Preparation in Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03157791
Recruitment Status : Completed
First Posted : May 17, 2017
Last Update Posted : May 23, 2018
Information provided by (Responsible Party):
University of Manitoba

Brief Summary:
This Clinical Trial is being conducted to study the effect of oral simethicone on the presence of bubbles during colonoscopy. The purpose of this study is to find out what effects (good and bad) the addition of oral simethicone to bowel preparation has on the ability to visualize the colon mucosa (bowel) during colonoscopy.

Condition or disease Intervention/treatment Phase
Colonoscopy Bowel Preparation Drug: Simethicone 180Mg Cap Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 471 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The endoscopist and endoscopy nurse will not know to which treatment arm the patient belongs as only the interviewing nurse will have taken down this information. This information does not travel with the patient to the endoscopy room. The patient is also instructed to not reveal to the endoscopist or endoscopy nurse if he or she has taken simethicone or not.
Primary Purpose: Diagnostic
Official Title: Addition of Oral Simethicone to Bowel Preparation in Colonoscopy
Actual Study Start Date : July 5, 2017
Actual Primary Completion Date : November 26, 2017
Actual Study Completion Date : November 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Simethicone

Arm Intervention/treatment
Experimental: Simethicone with Bowel Prep
Group A will receive 2 simethicone tablets (180mg each) so that one tablet is taken at the same time as each bowel preparation dose.
Drug: Simethicone 180Mg Cap
Simethicone Group A will take a total of 360mg prior to colonoscopy of Simethicone 180Mg Cap.
Other Name: Gas-X

No Intervention: Control
Group B will receive no simethicone tablets.

Primary Outcome Measures :
  1. Bubble Scale Score [ Time Frame: Will be completed immediately after colonoscopy is completed ]
    The scale grades the amount of bubbles present in the colon from 0 (none) to 3 (severe)

Secondary Outcome Measures :
  1. Ottawa Stool Scale [ Time Frame: Will be completed immediately after colonoscopy is completed ]
    The scale grades the degree of bowel preparation from 0 (no preparation) to 3 (entire colon mucosa seen well)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients receiving colonoscopy who are within 30km of Brandon Manitoba and no other exclusion criteria

Exclusion Criteria:

  • inability to provide informed consent, under 18 years old, inpatient, pregnancy, known hypersensitivity to simethicone, or excessive language barriers.

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): NCT03157791

Layout table for location information
Canada, Manitoba
Brandon Regional Health Centre
Brandon, Manitoba, Canada, r7a2b3
Sponsors and Collaborators
University of Manitoba
Layout table for investigator information
Study Director: Melissa Towle, RN Brandon Regional Health Centre
Study Director: Charlenn Skead, BA University of Manitoba
Layout table for additonal information
Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT03157791    
Other Study ID Numbers: B2017:056
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Manitoba:
Additional relevant MeSH terms:
Layout table for MeSH terms
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents