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Completed
NCT07084350
Combination of Lactulose and Polyethylene Glycol Electrolytes Powder (PEG-ELS) for Bowel Preparation in Type II Diabetes Mellitus Patients
Conditions: Type II Diabetes Mellitus
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: General Hospital of Shenyang Military Region
Location: Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area) Shenyang Liaoning
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.
Eligibility Criteria
Inclusion Criteria:
1. age 18\~75 years;
2. patients undergoing colonoscopy;
3. diagnosis of type II diabetes mellitus;
4. sign the informed consent form.
Exclusion Criteria:
1. severe heart, lung or liver diseases;
2. bowel resection;
3. intestinal obstruction and massive ascites;
4. women preparing for pregnancy or those who were pregnant and lactating;
5. mental disorders;
6. dysphagia;
7. allergy to any medication used for bowel preparation;
8. have used prokinetic agents (such as domperidone or mosapride) within 14 days prior to the colonoscopy;
9. galactose or fructose intolerance, lactase deficiency, galactosemia, or glucose-galactose malabsorption syndrome.
Source: ClinicalTrials.gov (NCT07084350). StuddyBuddy aggregates publicly available trial information.