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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral Hospital of Shenyang Military Region

About this trial

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

Qualifiers

age 18~75 years;

patients undergoing colonoscopy;

diagnosis of type II diabetes mellitus;

sign the informed consent form.

Disqualifiers

severe heart, lung or liver diseases;

bowel resection;

intestinal obstruction and massive ascites;

women preparing for pregnancy or those who were pregnant and lactating;

Trial design

Treatments tested in this trial

  • lactulose
  • PEG (solution given 4 L)

Treatment groups

254 Participants
are divided into 2 treatment groups