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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04504292

Enrollment

124

Registered

2020-08-07

Start date

2020-08-01

Completion date

2021-07-30

Last updated

2020-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inpatient Colonoscopy, Oral Sulfate Solution, Polyethelene Glycol

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).

Interventions

DRUGSUPREP Bowel Prep Kit

Bowel prep prior to colonoscopy

DRUGGolytely Oral Product

Bowel prep prior to colonoscopy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Failure of performing colonoscopy	6 months	Prep Adequacy

Contacts

Primary ContactRohan Modi, MD

modi@virginia.edu248-229-3907

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026