Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Colonoscopy Cleansing
1 other identifier
interventional
1,329
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2024
CompletedStudy Start
First participant enrolled
December 9, 2024
CompletedFirst Posted
Study publicly available on registry
December 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedDecember 11, 2024
December 1, 2024
9 months
December 8, 2024
December 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adequate bowel preparation rate
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 Outcomes (5)
Excellent bowel preparation rate
30minutes
BBPS score (including total score, left colon, transverse colon, and right colon)
30minutes
Adenoma detection rate
10 days
Bowel preparation completion rate
30minutes
Electrolyte levels
8 hours
Study Arms (3)
1L PEG + 50g Magnesium sulfate (Group A)
EXPERIMENTALTake 50g magnesium sulfate and 1L polyethylene glycol for bowel preparation before colonoscopy
3L PEG alone (Group B)
ACTIVE COMPARATORTake 3L polyethylene glycol for bowel preparation before colonoscopy
4L PEG alone (Group C)
ACTIVE COMPARATORTake 4L polyethylene glycol for bowel preparation before colonoscopy
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- years old, male or female
- To undergo screening, surveillance and diagnostic colonoscopy
- Signed written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changhai Hospitallead
- The First Affiliated Hospital of Nanchang Universitycollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- The Second Hospital of Hebei Medical Universitycollaborator
- Daping Hospital of Army Medical Universitycollaborator
- Ningjin People's Hospitalcollaborator
- Zibo Central Hospitalcollaborator
- Zhengzhou Central Hospitalcollaborator
- First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
- Affiliated Yueqing Hospital of Wenzhou Medical Universitycollaborator
- Qianfoshan Hospitalcollaborator
- The General Hospital of Western Theater Commandcollaborator
- Jiangmen Central Hospitalcollaborator
- The First Affiliated Hospital of Henan University of Science and Technologycollaborator
- LiuZhou People's Hospitalcollaborator
- The Fifth Affiliated Hospital of Zunyi Medical Collegecollaborator
- Yan'an University Affiliated Hospitalcollaborator
- 900 Hospital of Joint Logistics Support Force of PLAcollaborator
Related Publications (3)
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PMID: 33538338BACKGROUNDGe F, Kang X, Wang Z, Zhu H, Liao L, Wang M, Jia J, Lou L, Guo X, Pan Y, Wan J. Low-dose of magnesium sulfate solution was not inferior to standard regime of polyethylene glycol for bowel preparation in elderly patients: a randomized, controlled study. Scand J Gastroenterol. 2023 Jan;58(1):94-100. doi: 10.1080/00365521.2022.2106154. Epub 2022 Aug 3.
PMID: 35920250BACKGROUNDPark SS, Sinn DH, Kim YH, Lim YJ, Sun Y, Lee JH, Kim JY, Chang DK, Son HJ, Rhee PL, Rhee JC, Kim JJ. Efficacy and tolerability of split-dose magnesium citrate: low-volume (2 liters) polyethylene glycol vs. single- or split-dose polyethylene glycol bowel preparation for morning colonoscopy. Am J Gastroenterol. 2010 Jun;105(6):1319-26. doi: 10.1038/ajg.2010.79. Epub 2010 May 18.
PMID: 20485282BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaoshen Li, MD
Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2024
First Posted
December 11, 2024
Study Start
December 9, 2024
Primary Completion
August 31, 2025
Study Completion
August 31, 2025
Last Updated
December 11, 2024
Record last verified: 2024-12