Clinical trial NCT05465889: Efficacy and Safety of Oral Sulfate Solution on Bowel Preparation for Colonoscopy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Preparation for Colonoscopy
Keywords: colonoscopy
Bowel preparation
Sodium Potassium and Magnesium Sulfate
polyethylene glycol
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai Hospital of Integrated Traditional Chinese and Western Medicine
name: China-japan Friendship Hospital, Jilin University
name: Beijing Hospital
name: The First Affiliated Hospital of Nanchang University
name: Zhongshan Hospital Xiamen University
name: Henan Provincial People's Hospital
name: Hebei Provincial People's Hospital
name: Shandong University Qilu Hospital
First posted: 2022-07-20
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bowel preparation adequate rate
timeFrame: 30 minutes
Secondary outcomes:
measure: Boston bowel preparation scale (BBPS) score
timeFrame: 30 minutes
measure: Acceptability of laxatives by questionnaire survey
timeFrame: 12 hours
measure: Colonoscopy completion rate
timeFrame: 30 minutes
measure: Incidence of laxative-related adverse events assessed by clinical examinations
timeFrame: 8 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital, Naval Medical University
name: li.zhaoshen@hotmail.com li.zhaoshen@hotmail.com, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kluge MA, Williams JL, Wu CK, Jacobson BC, Schroy PC 3rd, Lieberman DA, Calderwood AH. Inadequate Boston Bowel Preparation Scale scores predict the risk of missed neoplasia on the next colonoscopy. Gastrointest Endosc. 2018 Mar;87(3):744-751. doi: 10.1016/j.gie.2017.06.012. Epub 2017 Jun 23.
citation: Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available.