NCT03157791

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
471

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 5, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2017

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

May 15, 2017

Last Update Submit

May 22, 2018

Conditions

ColonoscopyBowel Preparation

Keywords

simethicone

Outcome Measures

Primary Outcomes (1)

  • Bubble Scale Score

    The scale grades the amount of bubbles present in the colon from 0 (none) to 3 (severe)

    Will be completed immediately after colonoscopy is completed

Secondary Outcomes (1)

  • Ottawa Stool Scale

    Will be completed immediately after colonoscopy is completed

Study Arms (2)

Simethicone with Bowel Prep

EXPERIMENTAL

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

Control

NO INTERVENTION

Group B will receive no simethicone tablets.

Interventions

Simethicone 180Mg CapDRUG

Simethicone Group A will take a total of 360mg prior to colonoscopy of Simethicone 180Mg Cap.

Also known as: Gas-X
Simethicone with Bowel Prep

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brandon Regional Health Centre

Brandon, Manitoba, r7a2b3, Canada

Location

Related Publications (5)

  • Goldman J, Reichelderfer M. Evaluation of rapid colonoscopy preparation using a new gut lavage solution. Gastrointest Endosc. 1982 Feb;28(1):9-11. doi: 10.1016/s0016-5107(82)72956-6.

    PMID: 7056467BACKGROUND

  • Martel M, Barkun AN, Menard C, Restellini S, Kherad O, Vanasse A. Split-Dose Preparations Are Superior to Day-Before Bowel Cleansing Regimens: A Meta-analysis. Gastroenterology. 2015 Jul;149(1):79-88. doi: 10.1053/j.gastro.2015.04.004. Epub 2015 Apr 8.

    PMID: 25863216BACKGROUND

  • Matro R, Tupchong K, Daskalakis C, Gordon V, Katz L, Kastenberg D. The effect on colon visualization during colonoscopy of the addition of simethicone to polyethylene glycol-electrolyte solution: a randomized single-blind study. Clin Transl Gastroenterol. 2012 Nov 29;3(11):e26. doi: 10.1038/ctg.2012.16.

    PMID: 23238113BACKGROUND

  • Parikh VA, Khanduja KS. Use of simethicone during colonoscopy. Dis Colon Rectum. 1995 Sep;38(9):1007-8. doi: 10.1007/BF02049743. No abstract available.

    PMID: 7656734BACKGROUND

  • Ofstead CL, Wetzler HP, Johnson EA, Heymann OL, Maust TJ, Shaw MJ. Simethicone residue remains inside gastrointestinal endoscopes despite reprocessing. Am J Infect Control. 2016 Nov 1;44(11):1237-1240. doi: 10.1016/j.ajic.2016.05.016. Epub 2016 Aug 3.

    PMID: 27497824BACKGROUND

MeSH Terms

Interventions

SimethiconeCapsules

Intervention Hierarchy (Ancestors)

DimethylpolysiloxanesSiliconesSiloxanesOrganosilicon CompoundsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureDosage FormsPharmaceutical Preparations

Study Officials

  • Melissa Towle, RN

    Brandon Regional Health Centre

    STUDY DIRECTOR

  • Charlenn Skead, BA

    University of Manitoba

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 17, 2017

Study Start

July 5, 2017

Primary Completion

November 26, 2017

Study Completion

November 26, 2017

Last Updated

May 23, 2018

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)