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Combination of Lactulose and Polyethylene Glycol Electrolytes Powder (PEG-ELS) for Bowel Preparation in Type II Diabetes Mellitus Patients
Sponsor: General Hospital of Shenyang Military Region
Summary
Compared to the general population, diabetic patients have a significantly higher rate of inadequate bowel preparation. The European Society of Gastrointestinal Endoscopy (ESGE) guideline recommends polyethylene glycol (PEG) as the preferred bowel-cleansing agent, but there is currently no standardized bowel preparation protocol specifically for diabetic patients. Previous studies have shown that oral lactulose-based regimens or adding lactulose to the standard PEG protocol can improve bowel preparation quality, reduce adverse effects such as abdominal pain, bloating, nausea, and vomiting, and have no impact on blood glucose levels in diabetic patients after consuming 20g or 30g of lactulose. Herein, a multicenter randomized controlled trial(RCT) has been designed to explore the efficacy and safety of lactulose combined with polyethylene glycol electrolyte solution (PEG-ELS) for bowel preparation in patients with type II diabetes mellitus.
Official title: Efficacy and Safety of Oral Lactulose Combined With Polyethylene Glycol Electrolytes Powder (PEG-ELS) for Bowel Preparation in Type II Diabetes Mellitus Patients: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
254
Start Date
2025-08-25
Completion Date
2026-07-25
Last Updated
2025-08-14
Healthy Volunteers
No
Conditions
Interventions
lactulose
1. Two days before the colonoscopy: The patients should respectively take 30mL of lactulose orally on an empty stomach in the morning and at 8:00 PM of the same day, respectively. 2. One Day Before the Colonoscopy: The patients should take 30mL of lactulose orally at 7:00 PM. 3. On the Day of the Colonoscopy: For Morning Appointments:The patients should take 30mL of lactulose orally at 2:00 AM. For Afternoon Appointments:The patients should take 30mL of lactulose orally at 7:00 AM.
PEG (solution given 4 L)
1. One Day Before the Colonoscopy: The patients should take 2000mL of PEG solution at 8:00 PM, and drink the entire solution within 2 hours. 2. On the Day of the Colonoscopy: For Morning Appointments: The patients should take 2000mL of PEG solution at 3:00 AM and drink the entire solution within 2 hours. For Afternoon Appointments: The patients should take 2000mL of PEG solution at 7:00 AM and drink the entire solution within 2 hours.
Locations (1)
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, China