Combination of Lactulose and Polyethylene Glycol Electrolytes Powder (PEG-ELS) for Bowel Preparation in Type II Diabetes Mellitus Patients

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status: Not yet enrolling

Conditions: Type II Diabetes Mellitus

Treatments: Drug: PEG (solution given 4 L); Drug: lactulose

Study type: Interventional

Funder types: Other

Identifiers

NCT07084350

XHNKKY-OLPG

Details and patient eligibility

About

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.

Full description

Overall, 254 patients with type II diabetes mellitus will be enrolled. They will be randomly assigned at a ratio of 1:1 to the PEG group and lactulose +PEG group. The primary endpoint is the percentage of adequate bowel preparation. Secondary endpoints include the detection rates of polyps or adenomas and the incidence adverse reactions associated with bowel preparation (nausea, vomiting, abdominal pain, bloating, etc.).

Enrollment: 254 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age ≥18years;
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 4 weeks prior to the colonoscopy;
9. galactose or fructose intolerance, lactase deficiency, galactosemia, or glucose-galactose malabsorption síndrome.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

254 participants in 2 patient groups

Lac+PEG-ELS group

Experimental group

Description:

Oral lactulose combined with PEG-ELS

Treatment:

Drug: lactulose

Drug: PEG (solution given 4 L)

PEG-ELS group

Active Comparator group

Description:

Only PEG-ELS

Treatment:

Drug: PEG (solution given 4 L)