Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Colonoscopy Cleansing

Not Applicable

Not yet recruiting

• Conditions: Bowel Preparation for Colonoscopy
• Interventions: Drug: 1L PEG + 50g magnesium sulfate; Drug: 3L PEG; Drug: 4L PEG

• Registration Number: NCT06728839
• Lead Sponsor: Changhai Hospital

Brief Summary

Magnesium salts such as magnesium citrate are often combined with polyethylene glycol to make the intestinal preparation before colonoscopy, which has shown high cleaning efficacy. Magnesium sulfate combined with polyethylene glycol is less used in the world. This multicenter, randomized, controlled trial is aimed at to evaluate the efficacy and safety of magnesium sulfate combined with low-volume polyethylene glycol for preoperative bowel preparation for colonoscopy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-08
• Study First Submitted QC: 2024-12-08
• Last Update Submitted: 2024-12-08
• Study Start: 2024-12-09
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1329

Inclusion Criteria

• 18-75 years old, male or female
• To undergo screening, surveillance and diagnostic colonoscopy
• Signed written informed consent

Exclusion Criteria

• Subjects with therapeutic colonoscopy for colorectal polyps
• Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder, or acute gastrointestinal bleeding
• Subjects with confirmed or suspected colorectal cancer, inflammatory bowel disease, toxic colitis, or toxic megacolon
• Subjects with renal or liver dysfunction, congestive heart failure or rhabdomyolysis
• Subjects with ascites, suspected electrolyte abnormalities, or uncorrected dehydration
• Subjects with constipation (<3 times a week, difficult defecation, dry stool, less amount)
• Subjects with serious cardiac and cerebrovascular diseases,suffering from metabolic disease or endocrine disease
• Subjects who had previously undergone colorectal resection
• Women with positive pregnancy tests or pregnancy plans, and women in lactation or allergic to the investigational drugs and their ingredients
• Subjects who are participating in other clinical trials or receiving special drugs
• Subjects with any other conditions that the investigator considered inappropriate for inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1L PEG + 50g Magnesium sulfate (Group A)	1L PEG + 50g magnesium sulfate	Take 50g magnesium sulfate and 1L polyethylene glycol for bowel preparation before colonoscopy
3L PEG alone (Group B)	3L PEG	Take 3L polyethylene glycol for bowel preparation before colonoscopy
4L PEG alone (Group C)	4L PEG	Take 4L polyethylene glycol for bowel preparation before colonoscopy

Primary Outcome Measures

Name	Time	Method
Adequate bowel preparation rate	30minutes	Defined as the proportion of participants with score ≥ 2 for all colon segment (right-side colon, transverse colon, and left-side colon) according to the Boston Bowel Preparation Scale

Secondary Outcome Measures

Name	Time	Method
Electrolyte levels	8 hours
Excellent bowel preparation rate	30minutes	The proportion of participants with total score ≥ 8 according to Boston Bowel Preparation Scale.
BBPS score (including total score, left colon, transverse colon, and right colon)	30minutes
Adenoma detection rate	10 days
Bowel preparation completion rate	30minutes