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

December 8, 2024 updated by: Changhai Hospital

Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Bowel Preparation Before Colonoscopy: A Multicentre, Randomized, Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1329

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1L PEG + 50g Magnesium sulfate (Group A)
Take 50g magnesium sulfate and 1L polyethylene glycol for bowel preparation before colonoscopy
Drug: 1L PEG + 50g magnesium sulfate
Subjects in Group A will use a regimen combining magnesium sulfate and polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. 1 litter of polyethylene glycol is taken at 8pm the day before the colonoscopy and 50 gram of magnesium sulfate is taken 4-6 hours before the colonoscopy, and then drink 2000 ml of water within 2 hours.
Active Comparator: 3L PEG alone (Group B)
Take 3L polyethylene glycol for bowel preparation before colonoscopy
Drug: 3L PEG
Subjects in Group B will use a regimen with 3L polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. The 3 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 2 liters taken 4-6 hours before the colonoscopy.
Active Comparator: 4L PEG alone (Group C)
Take 4L polyethylene glycol for bowel preparation before colonoscopy
Drug: 4L PEG
Subjects in Group C will use a regimen with 4L polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. The 4 liters of polyethylene glycol solution is taken in split dosing, with 2 liters taken at 8pm the day before the colonoscopy and 2 liters taken 4-6 hours before the colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequate bowel preparation rate
Time Frame: 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
30minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

The First Affiliated Hospital of Nanchang University
The Second Hospital of Hebei Medical University
First Affiliated Hospital Xi'an Jiaotong University
The First Affiliated Hospital of Zhengzhou University
Qianfoshan Hospital
The First Affiliated Hospital of Henan University of Science and Technology
The General Hospital of Western Theater Command
Zibo Central Hospital
Jiangmen Central Hospital
Yan'an University Affiliated Hospital
LiuZhou People's Hospital
The Fifth Affiliated Hospital of Zunyi Medical College
Yueqing People's Hospital
Zhengzhou Central Hospital
Daping Hospital of Army Medical University
900th hospital of the joint logistics team, PLA
Ningjin People's Hospital

Investigators

  • Principal Investigator: Zhaoshen Li, MD, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 9, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

December 8, 2024

First Submitted That Met QC Criteria

December 8, 2024

First Posted (Estimated)

December 11, 2024

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 8, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGSP-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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