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

Third Military Medical University

Status: Enrolling

Conditions: Bowel Preparation Before Colonoscopy

Treatments: Dietary Supplement: electrolyte beverages

Study type: Interventional

Funder types: Other

Identifiers

NCT06675227

20240924

2022XLC05 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,766 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

2,766 participants in 2 patient groups

Drinking Water Group

No Intervention group

Description:

This group will apply the ordinary drinking water as the solvents for 2L PEG to dissolve.

Electrolyte Beverages Group

Experimental group

Description:

This group will apply the electrolyte beverages(Alienergy) instead of ordinary drinking water as the solvents for 2L PEG to dissolve.

Treatment:

Dietary Supplement: electrolyte beverages