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

ConditionType II Diabetes Mellitus
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • lactulose

    Drug

    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)

    Drug

    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.

Treatment groups

254 Participants
are divided into 2 treatment groups
Group A: Lac+PEG-ELS groupExperimental treatment 2 interventions
Group B: PEG-ELS groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adequate Bowel Preparation Rate

Time frame
3 days

Secondary outcomes

1

Adenoma and/or polyp detection rate (ADR/PDR)

Time frame
3 days
2

Adverse reactions rate associated with bowel preparation

Time frame
3 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

General Hospital of Shenyang Military Region

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: