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

NCT04504292 | Unknown DMC

• 1 other identifier: 21980
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Inpatient Colonoscopy; Oral Sulfate Solution; Polyethelene Glycol

Outcome Measures

Primary Outcomes (1)

• Non-inferiority design to compare SUPREP to GoLytely (standard of care)

  Boston Bowel Preparation Score

  6 months

Secondary Outcomes (1)

• Failure of performing colonoscopy

  6 months

Study Arms (2)

Oral sulfate solution (SuPREP arm)

EXPERIMENTAL

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.

Drug: SUPREP Bowel Prep Kit

Polyethelene Glycol (GoLytely arm)

ACTIVE COMPARATOR

Polyethylene Glycol Bowel Prep Kit

Drug: Golytely Oral Product

Interventions

SUPREP Bowel Prep Kit DRUG

Bowel prep prior to colonoscopy

Oral sulfate solution (SuPREP arm)

Golytely Oral Product DRUG

Bowel prep prior to colonoscopy

Polyethelene Glycol (GoLytely arm)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to consent (patient or POA)

Sponsors & Collaborators

• University of Virginia: lead

Related Publications (1)

• Lee HH, Lim CH, Kim JS, Cho YK, Lee BI, Cho YS, Lee IS, Choi MG. Comparison Between an Oral Sulfate Solution and a 2 L of Polyethylene Glycol/Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy. J Clin Gastroenterol. 2019 Nov/Dec;53(10):e431-e437. doi: 10.1097/MCG.0000000000001137.

  PMID: 30308546 BACKGROUND

Central Study Contacts

Rohan Modi, MD

CONTACT

248-229-3907; modi@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 7, 2020
• Study Start: August 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: July 30, 2021
• Last Updated: August 11, 2020

Record last verified: 2020-08