Oral Sulfate Solution (SUPREP) Versus Polyethylene Glycol (PEG) Plus Ascorbic Acid

Bo-In Lee

Status and phase: Completed; Phase 4

Conditions: Cathartic Colon

Treatments: Drug: 2-L PEG/Asc; Drug: Oral sulfate solution (OSS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02761213

KC16MISV0004

Details and patient eligibility

About

The aims of the present study is to compare oral sulfate solution (OSS) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) for bowel cleansing efficacy.

Full description

High-quality bowel cleansing is critical to effective colonoscopy. Studies in the past decade have demonstrated that many clinical practices continue to have rates of adequate preparation as low as 60% to 80%.

Low-volume preparations for colonoscopy are designed to improve patient tolerability, another important aspect of bowel preparation. In addition, low-volume preparations should ideally not sacrifice efficacy. There are few data comparing the efficacy of available low-volume bowel preparations.

In this study, we describe a prospective, single-blind, randomized, controlled trial comparing oral sulfate solution (OSS) (SUPREP, Braintree Laboratories, Braintree, Mass) with low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc).

Enrollment: 200 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• people who receive colonoscopy
• aged : 18-80
• people who sign the consent

Exclusion criteria

• those aged over 80 years
• the disabled
• intestinal obstruction
• severe constipation
• previous history of bowel resection
• liver cirrhosis
• heart failure or ischemic heart disease within 6 months
• inflammatory bowel disease
• pregnant women
• severe renal insufficiency
• people who refuse to sign the consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

Oral sulfate solution (OSS)

Experimental group

Description:

oral sulfate solution (OSS)

Treatment:

Drug: Oral sulfate solution (OSS)

2-L PEG/Asc

Active Comparator group

Description:

low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc)

Treatment:

Drug: 2-L PEG/Asc