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

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

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.

Inclusion Criteria:

• Voluntarily participate and sign informed consent;
• Scheduling screening, surveillance, and diagnostic colonoscopy;
• Necessary body fluid and blood electrolyte balance (the test values of potassium, sodium, chlorine, calcium and magnesium in blood biochemistry during screening period should not exceed 10% of the normal range).

Exclusion Criteria:

• Subjects who used drugs that affect gastrointestinal dynamics, affect kidney function, or increase the risk of fluid retention or electrolyte disorders within 7 days before the start of the trial;
• Subjects with serious cardiac and cerebrovascular diseases, bronchial and lung diseases, suffering from metabolic disease or endocrine disease, abnormal blood clotting mechanism, malignant tumor, electrolyte abnormalities, epilepsy, Renal or liver dysfunction;
• Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder or acute gastrointestinal bleeding;
• Subjects with acute severe colitis (such as active severe inflammatory bowel disease, acute bacterial dysentery, diverticulitis, etc.);
• Subjects with a history of major gastrointestinal surgery (e.g. gastric bypass, gastric septal surgery, colostomy, colectomy, etc.);
• Subjects with constipation or suspected severe gastric motility disorder;
• Women with positive pregnancy tests or pregnancy plans, and women in lactation;
• Subjects who have participated in any other clinical trials within the last 3 months;
• Subjects with any other conditions that the investigator considered inappropriate for inclusion.