Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation (EBSBP-01)

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.

Study Overview

• Status: Recruiting
• Conditions: Bowel Preparation Before Colonoscopy
• Intervention / Treatment: Dietary supplement: electrolyte beverages

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.

• Study Type: Interventional
• Enrollment (Estimated): 2766
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kun Xv; Phone Number: 13500321218; Email: vdtong@163.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • Army Medical Center
      • Contact: WeiDong Tong, MD; Phone Number: +862368729356; Email: vdtong@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy individuals or those with mild or well-controlled chronic diseases.
2. Patients scheduled for outpatient colonoscopy.
3. Patients prescribed sodium phosphate or polyethylene glycol for bowel preparation.
4. Willing to participate and sign the informed consent form.
5. Age ≥18 years
6. ECOG performance status <2

Exclusion Criteria:

1. Patients who refuse to participate in the study.
2. Patients requiring enema preparation.
3. Uncontrolled hypertension.
4. Patients with diabetes.
5. Pregnant patients.
6. Suspected bowel obstruction.
7. Risk of aspiration.
8. Patients with severe ulcerative colitis, gastric retention, bowel perforation, toxic colitis, or megacolon.
9. Patients with severe systemic diseases (including NYHA class 3-4 heart failure, Child-Pugh class C liver failure).
10. Patients with a known allergy to polyethylene glycol.
11. Patients with a history of major gastrointestinal surgery or any other conditions that may interfere with study outcomes or adherence.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Drinking Water Group; This group will apply the ordinary drinking water as the solvents for 2L PEG to dissolve.
Experimental: Electrolyte Beverages Group; This group will apply the electrolyte beverages(Alienergy) instead of ordinary drinking water as the solvents for 2L PEG to dissolve.	Dietary supplement: electrolyte beverages; Using Electrolyte Beverages as replacement for water to dissolve PEG(2L plan) in bowel preparation process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the time point when patients finished colonscopy (within a week).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From enrollment to the time point when patients finished colonscopy (within a week).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Willingness to Repeat	The willingness of patients to undergo a repeat colonoscopy after the procedure will be recorded and analyzed. This will be quantified using a Yes/No format, and the proportion of willingness in each group will be calculated.	From enrollment to the time point before colonscopy(within a week).
Bowel Preparation Time	The total time (in minutes) required for each patient to complete 2000 ml of bowel preparation solution will be recorded, and the average time and standard deviation will be calculated.	From enrollment to the time point before colonscopy(within a week).

Collaborators and Investigators

• Sponsor: Third Military Medical University
• Collaborators: The thirteenth people's hospital of Chonqing; Fuling people's hospital of Chongqing
• Investigators: Principal Investigator: Weidong Tong, MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 3, 2024
• First Submitted That Met QC Criteria: November 3, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: bowel preparation; Electrolyte Beverages
• Other Study ID Numbers: 20240924; 2022XLC05 (Other Grant/Funding Number: Army Medical University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No