Bowel Preparation Before ColonoscopyEBSBP-01NCT06675227
Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation
A study testing electrolyte beverages in people with Bowel Preparation Before Colonoscopy, run by Third Military Medical University at 1 site in China.
Trial summary
Using Electrolyte Beverages as replacement for water to dissolve PEG(2L plan) in bowel preparation process. The aim of this study is to test whether Electrolyte Beverages as solvents can improve the cleanness of bowel preparation and the satisfaction of patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation Before Colonoscopy
- What is being tested?
- electrolyte beverages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,766 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2024to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals or those with mild or well-controlled chronic diseases.
- Patients scheduled for outpatient colonoscopy.
- Patients prescribed sodium phosphate or polyethylene glycol for bowel preparation.
- Willing to participate and sign the informed consent form.
- Age ≥18 years
- ECOG performance status <2
Who cannot join
- Patients who refuse to participate in the study.
- Patients requiring enema preparation.
- Uncontrolled hypertension.
- Patients with diabetes.
- Pregnant patients.
- Suspected bowel obstruction.
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- Risk of aspiration.
- Patients with severe ulcerative colitis, gastric retention, bowel perforation, toxic colitis, or megacolon.
- Patients with severe systemic diseases (including NYHA class 3-4 heart failure, Child-Pugh class C liver failure).
- Patients with a known allergy to polyethylene glycol.
- Patients with a history of major gastrointestinal surgery or any other conditions that may interfere with study outcomes or adherence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Army Medical Center
Chongqing, Chongqing Municipality, 400042
WeiDong Tong, MD, +862368729356, vdtong@163.com
About this study
Official title: Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation: A Single-Blind, Prospective, Multicenter Randomized Controlled Trial
Using Electrolyte Beverages as replacement for water to dissolve PEG(2L plan) in bowel preparation process.
The aim of this study is to test whether Electrolyte Beverages as solvents can improve the cleanness of bowel preparation and the satisfaction of patients.
Read the detailed description
The application of electronic colonoscopy has shown a significant upward trend in the diagnosis, screening, and health check-ups for colorectal diseases.
To clean the colon, patients must consume several liters of bowel preparation solution in a short period before the procedure.
However, a significant number of patients experience nausea or even vomiting, preventing them from completing the recommended dose, resulting in suboptimal bowel preparation and affecting the colonoscopy process.
Therefore, the investigators have designed a protocol that uses sugar-free electrolyte beverages instead of regular drinking water as a solvent for the laxative solution. By improving the taste of the oral solution and increasing the electrolyte content, the investigators aim to enhance patient compliance with colonoscopy preparation and ultimately assess the effectiveness of bowel cleansing.
- Conditions
- Bowel Preparation Before Colonoscopy
- Being tested
- electrolyte beverages
- Keywords
- bowel preparation, Electrolyte Beverages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrolyte beveragesDietary supplement
Using Electrolyte Beverages as replacement for water to dissolve PEG(2L plan) in bowel preparation process.
| Study group | Role | What they receive |
|---|---|---|
| Drinking Water Group | No intervention | This group will apply the ordinary drinking water as the solvents for 2L PEG to dissolve. |
| Electrolyte Beverages Group | Experimental | This group will apply the electrolyte beverages(Alienergy) instead of ordinary drinking water as the solvents for 2L PEG to dissolve. Receives: Dietary Supplement: electrolyte beverages |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Boston Bowel Preparation Scale
The BBPS is a standardized 9-point assessment scale for the colon. The structure of the colon is divided into its three segments: right colon, transverse colon, and left colon. Each segment is classified from 0 to 3 depending on the degree of soiling. The sum total of the three segments represents the degree of soiling, so that a total ≤ 5 points shows poor bowel preparation, while 6-7 shows good bowel preparation, and ≥ 8 very good bowel preparation.
Measured: From enrollment to the time point when patients finished colonscopy (within a week).
Secondary outcomes (2)
The Palatability
The palatability of different bowel preparation regimens will be assessed using a 4-point scale. The scoring system is as follows: 1 = very poor, 2 = poor, 3 = good, 4 = very good. Each participant's score will be collected and statistically analyzed.
Measured: From enrollment to the time point when patients finished colonscopy(within a week).
Lesion Detection Rate
The proportion of polyps, tumors, inflammatory bowel disease, and diverticulosis detected during colonoscopy under different bowel preparation regimens will be recorded. The detection rate will be expressed as a percentage, and differences between the groups will be analyzed.
Measured: From enrollment to the time point when patients finished colonscopy (within a week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start11 Nov 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Preparation Before ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 2,766 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The thirteenth people's hospital of Chonqing, People's Hospital of Chongqing
- Responsible party
- Principal investigator, Weidong Tong, Third Military Medical University
- Investigators
- Weidong Tong, MD, Principal investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675227
- Sponsor's protocol ID
- 20240924
- Other IDs
- 2022XLC05
- Acronym
- EBSBP-01
- Status last verified
- Oct 2026
- First submitted
- 3 Nov 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No