- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07608120
Electrolyte Beverage Combined With Polyethylene Glycol for Colonoscopy Bowel Preparation
May 24, 2026 updated by: Nanfang Hospital, Southern Medical University
Randomized Controlled Trial of Different Ratios of Electrolyte Beverage and Water Combined With Polyethylene Glycol on Bowel Preparation Quality and Ingestion Rhythm Before Colonoscopy
This randomized controlled trial aims to evaluate the effects of different ratios of electrolyte beverage and water combined with polyethylene glycol (PEG) on bowel preparation quality before colonoscopy.
Participants undergoing elective colonoscopy will be randomly assigned to one of three bowel preparation regimens: PEG prepared with water only, PEG prepared with a low ratio of electrolyte beverage and water, or PEG prepared with a medium ratio of electrolyte beverage and water.
The primary outcome is adequate bowel preparation assessed by the Boston Bowel Preparation Scale (BBPS).
Secondary outcomes include bowel preparation completion rate, tolerability, adverse events, repeat colonoscopy rate, adenoma detection rate, and ingestion rhythm characteristics during bowel preparation.
This study also aims to explore whether electrolyte beverage-assisted bowel preparation may improve bowel cleansing quality by influencing participants' ingestion rhythm and adherence during PEG intake.
Study Overview
Status
Recruiting
Study Type
Interventional
Enrollment (Estimated)
405
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
- Name: Aimin Li
- Phone Number: +86 13580317630
- Email: lam0725@163.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Recruiting
- Nanfang Hospital, Southern Medical University
-
Contact:
- Aimin Li
- Phone Number: +86 13580317630
- Email: lam0725@163.com
-
-
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:
- Adults aged 18-75 years scheduled to undergo elective colonoscopy
- Meet the standard clinical indications for colonoscopy;
- Able to understand and comply with the bowel preparation procedure and complete oral polyethylene glycol (PEG) intake as required;
- Able to comply with study-related data collection and follow-up;
- Provide written informed consent voluntarily.
Exclusion Criteria:
- Previously diagnosed colorectal cancer, intestinal obstruction, or suspected intestinal obstruction;
- Active gastrointestinal bleeding or a definite history of gastrointestinal bleeding within the past 4 weeks (including melena, hematochezia, or hematemesis);
- Severe renal insufficiency, decompensated heart failure, significant electrolyte imbalance, or other conditions unsuitable for PEG bowel preparation;
- Known allergy to polyethylene glycol or components of the electrolyte beverage used in the study;
- Pregnant or breastfeeding women;
- Any other condition considered by the investigators to make the participant unsuitable for the study.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Water Group
Participants receive polyethylene glycol (PEG) prepared with water only for bowel preparation before colonoscopy.
|
Polyethylene glycol (PEG) prepared with water only for bowel preparation before colonoscopy.
|
|
Experimental: Low-dose Electrolyte Beverage Group
Participants receive polyethylene glycol (PEG) prepared with electrolyte beverage and water at a 1:3 ratio for bowel preparation before colonoscopy.
|
Polyethylene glycol (PEG) prepared with electrolyte beverage and water at a 1:3 ratio for bowel preparation before colonoscopy.
|
|
Experimental: Medium-dose Electrolyte Beverage Group
Participants receive polyethylene glycol (PEG) prepared with electrolyte beverage and water at a 1:1 ratio for bowel preparation before colonoscopy.
|
Polyethylene glycol (PEG) prepared with electrolyte beverage and water at a 1:1 ratio for bowel preparation before colonoscopy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adequate Bowel Preparation Rate
Time Frame: At the time of colonoscopy on Day 1
|
Adequate bowel preparation is defined as a total Boston Bowel Preparation Scale (BBPS) score ≥6 with each colonic segment score ≥2 during colonoscopy.
|
At the time of colonoscopy on Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Boston Bowel Preparation Scale Score
Time Frame: At the time of colonoscopy on Day 1
|
Total Boston Bowel Preparation Scale (BBPS) score assessed during colonoscopy.
|
At the time of colonoscopy on Day 1
|
|
Bowel Preparation Completion Rate
Time Frame: During bowel preparation within 1 hour before colonoscopy on Day 1
|
Proportion of participants who complete the planned polyethylene glycol bowel preparation within 60 minutes.
|
During bowel preparation within 1 hour before colonoscopy on Day 1
|
|
Adverse Event Rate
Time Frame: During bowel preparation within 1 hour before colonoscopy on Day 1
|
Incidence of adverse events during bowel preparation, including nausea, vomiting, abdominal distension, abdominal pain, dizziness, and fatigue.
|
During bowel preparation within 1 hour before colonoscopy on Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
May 18, 2026
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
May 31, 2027
Study Registration Dates
First Submitted
May 18, 2026
First Submitted That Met QC Criteria
May 24, 2026
First Posted (Actual)
May 27, 2026
Study Record Updates
Last Update Posted (Actual)
May 27, 2026
Last Update Submitted That Met QC Criteria
May 24, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NFEC-2026-307
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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