NCT05465889

Efficacy and Safety of Oral Sulfate Solution on Bowel Preparation for Colonoscopy

Comparison of the Efficacy and Safety of Oral Sulfate Solution and 3-liter Polyethylene Glycol on Bowel Preparation Before Colonoscopy: a Multicenter Randomized Controlled Phase III Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

To evaluate whether oral sulfate solution used for colon cleaning in adults prior to colonoscopy was not inferior to 3-liter polyethylene glycol in the proportion of subjects with BBPS score (total colon) ≥6 after colonoscopy

Detailed description

Polyethylene glycol (PEG) is the most widely used laxative at present, but volume of oral PEG liquid is large and the taste of PEG is not good, so some patients could not take enough laxative to complete bowel preparation. Oral sulfate solution containing sodium sulfate, magnesium sulfate, and potassium sulfate as active ingredients was developed as osmotic laxative for bowel cleansing preparation. The OSS works on the principle that sulfate is a poorly absorbed anion. Compared to traditional magnesium sulfate solution, OSS not only tastes better, but also reduces the occurrence of electrolyte disturbances.

Conditions

• Bowel Preparation for Colonoscopy

Interventions

Type	Name	Description
DRUG	Oral sulfate solution (OSS)	OSS contained 17.5 g sodium sulfate, 3.13 g potassium sulfate, 1.6 g magnesium sulfate, and flavoring agents in an aqueous liquid form supplied in a 177 mL bottle. Take 177ml sodium, potassium and magnesium sulfates oral solution (diluted to 480ml) within 30 minutes 14-16 hours before colonoscopy, followed by two doses of 480ml warm water within 1 hour; Repeat the procedure 3-4 hours before colonoscopy.
DRUG	Polyethylene Glycol Electrolyte	Take 1000 ml polyethylene glycol electrolyte solution within 1 hour at 8 p.m. the day before colonoscopy; take 2000 ml polyethylene glycol electrolyte solution within 2 hour 4-6 hours before colonoscopy.

Timeline

• Start date: 2019-05-15
• Primary completion: 2020-01-09
• Completion: 2020-03-15
• First posted: 2022-07-20
• Last updated: 2022-07-26

Locations

1 site across 1 country: China