Pilot Study to Assess Tolerability and Feasibility of Oral Sulfate Solution (SUPREP) in Hospitalized Patients

Not Applicable

• Conditions: Polyethelene Glycol; Inpatient Colonoscopy; Oral Sulfate Solution
• Interventions: Drug: Golytely Oral Product; Drug: SUPREP Bowel Prep Kit

• Registration Number: NCT04504292
• Lead Sponsor: University of Virginia

Brief Summary

This study will test the efficacy, tolerability, and feasibility of an oral sulfate solution (SUPREP) for inpatient colonoscopy preparation, compared to the standard of care (GoLytely). The hypothesis is that SUPREP will be well tolerated and non-inferior to standard polyethylene glycol bowel preparation for colonoscopies in an inpatient setting. To test this, at least 124 subjects who are undergoing an inpatient colonoscopy will be randomized to receive either SUPREP or standard of care. The Boston Bowel Preparation Score will be collected as standard of care for both groups. Safety will be monitored from standard of care blood tests and ECG (when indicated). Subjects will be given a survey to assess how tolerable they found the procedure.

A non-inferiority design will be used to compare SUPREP to the standard of care polyethylene glycol preparation. Data analysis will be performed on Boston Bowel Preparation Score and rate of failure of preparation (measured as number of successful subsequent colonoscopies).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08-01
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-07
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-11
• Primary Completion: 2021-05-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Patients will be approached with consent for the study only if there is a clinical indication for pursuing an inpatient colonoscopy

Exclusion Criteria

• Inability to consent (patient or POA)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polyethelene Glycol (GoLytely arm)	Golytely Oral Product	Polyethylene Glycol Bowel Prep Kit
Oral sulfate solution (SuPREP arm)	SUPREP Bowel Prep Kit	Per the package insert: The dose for colon cleansing requires administration of two bottles of SUPREP Bowel Prep Kit. Each bottle is administered as 16 oz of diluted SUPREP solution with an additional 1quart of water taken orally. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts (approximately 2.8 L) taken orally prior to the colonoscopy outlined below under frequency. Two 6 oz bottles of oral solution: Each 6 oz bottle contains: sodium sulfate 17.5 g, potassium sulfate 3.13 g, magnesium sulfate 1.6 g.

Primary Outcome Measures

Name	Time	Method
Non-inferiority design to compare SUPREP to GoLytely (standard of care)	6 months	Boston Bowel Preparation Score

Secondary Outcome Measures

Name	Time	Method
Failure of performing colonoscopy	6 months	Prep Adequacy