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

Inpatient Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04504292
• Other study ID #: 21980
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: August 2020
• Source: University of Virginia
• Contact: Rohan Modi, MD
• Phone: 248-229-3907
• Email: modi[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: July 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Inpatient Colonoscopy
• Oral Sulfate Solution
• Polyethelene Glycol

Intervention

Drug:
• SUPREP Bowel Prep Kit
Bowel prep prior to colonoscopy
• Golytely Oral Product
Bowel prep prior to colonoscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority design to compare SUPREP to GoLytely (standard of care)	Boston Bowel Preparation Score	6 months
Secondary	Failure of performing colonoscopy	Prep Adequacy	6 months