A Comparison of 5 Low Volume Bowel Preparations

Bowel Preparation for Colonoscopy Clinical Trial

Official title:

A Randomized Comparison of Five Low Volume Bowel Preparations for Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719653
• Other study ID #: 1220121180
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2012
• Last updated: March 23, 2017
• Start date: October 2012
• Est. completion date: September 2014

Study information

• Verified date: March 2017
• Source: Gastroenterology Services, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and SUPREP to see which preparation cleanses the colon best and which preparation is best tolerated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1079
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study. We would prefer to exclude as few groups as possible since in clinical practice these less well studied groups often need a colonoscopy and will need to have a colonoscopy preparation.

Exclusion Criteria:

1. Patients who are allergic (this is very rare) or intolerant to any of the study drugs.

2. Patients who are pregnant.

3. Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded.

4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.

5. Patients with known renal disease (baseline creatinine greater than 1.50 mg/dl) will need to be excluded due to the magnesium in SUPREP which is contraindicated in patients with significant renal disease.

Related Conditions & MeSH terms

• Bowel Preparation for Colonoscopy

Intervention

Drug:
• MiraLAX
MiraLAX consumed as described in each arm.

Other:
• Gatorade
Gatorade consumed as described in each arm.

Drug:
• MoviPrep
MoviPrep consumed as described in each arm.
• SUPREP
SUPREP consumed as described in each arm.

Locations

Country	Name	City	State
United States	Gastroenterology Services	Downers Grove	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Gastroenterology Services, Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gerard DP, Foster DB, Holden JL, Kang J, Raiser MW. Clinical Trial of 1000 Subjects Randomized to 5 Low-Volume Bowel Preparations for Colonoscopy and Their Acceptance of Split-Dose Bowel Preparations. J Clin Gastroenterol. 2016 Jul 18. [Epub ahead of prin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chicago Bowel Preparation Scale	The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).	At completion of colonoscopy - day 1
Secondary	Boston Bowel Preparation Scale	The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).	At completion of colonoscopy - day 1
Secondary	Adequate/Inadequate Scale	The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.	At completion of colonoscopy - day 1