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

University of Virginia

Status: Unknown

Conditions: Oral Sulfate Solution; Polyethelene Glycol; Inpatient Colonoscopy

Treatments: Drug: Golytely Oral Product; Drug: SUPREP Bowel Prep Kit

Study type: Interventional

Funder types: Other

Identifiers

NCT04504292

21980

Details and patient eligibility

About

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).

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

Oral sulfate solution (SuPREP arm)

Experimental group

Description:

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.

Treatment:

Drug: SUPREP Bowel Prep Kit

Polyethelene Glycol (GoLytely arm)

Active Comparator group

Description:

Polyethylene Glycol Bowel Prep Kit

Treatment:

Drug: Golytely Oral Product