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NCT Number: NCT07084350

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

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.

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Key information

Conditions

Type II Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Shenyang, Liaoning, 110840, China

About this study

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.).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18~75 years;
  • patients undergoing colonoscopy;
  • diagnosis of type II diabetes mellitus；
  • sign the informed consent form.

Exclusion criteria

  • severe heart, lung or liver diseases;
  • bowel resection;
  • intestinal obstruction and massive ascites;
  • women preparing for pregnancy or those who were pregnant and lactating;
  • mental disorders;
  • dysphagia;
  • allergy to any medication used for bowel preparation;
  • have used prokinetic agents (such as domperidone or mosapride) within 14 days prior to the colonoscopy;
  • galactose or fructose intolerance, lactase deficiency, galactosemia, or glucose-galactose malabsorption syndrome.

Treatment and study plan

Lactulose

Drug
  • 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.
  • One Day Before the Colonoscopy: The patients should take 30mL of lactulose orally at 7:00 PM.
  • 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
  • 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.
  • 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.

Primary outcomes

  1. Adequate Bowel Preparation Rate

    Time frame: 3 days

Secondary outcomes

  1. Excellent Bowel Preparation Rate

    Time frame: 3 days

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

    Time frame: 3 days

  3. Adverse reactions rate associated with bowel preparation

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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