NCT07084350Completed
Combination of Lactulose and Polyethylene Glycol Electrolytes Powder (PEG-ELS) for Bowel Preparation in Type II Diabetes Mellitus Patients
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
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 300 (actual)
- First submitted
- 17 Jul 2025
- Start date
- 4 Sept 2025
- Primary completion date
- 18 May 2026
- Lead sponsor
- General Hospital of Shenyang Military Region
- Diseases
- Type 2 diabetes
- NCT number
- NCT07084350
What you commit to
- Study type: Interventional
- Participants enrolled: 300
- From 4 Sept 2025 to the primary completion date, 18 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- bowel resection;
- have used prokinetic agents (such as domperidone or mosapride) within 14 days prior to the colonoscopy;
Other illness
- severe heart, lung or liver diseases;
- mental disorders;
- allergy to any medication used for bowel preparation;
Lab values
- galactose or fructose intolerance, lactase deficiency, galactosemia, or glucose-galactose malabsorption syndrome.
Other
- intestinal obstruction and massive ascites;
- women preparing for pregnancy or those who were pregnant and lactating;
- dysphagia;
Who the study is looking for
- age 18\~75 years;
- patients undergoing colonoscopy;
- diagnosis of type II diabetes mellitus；
- sign the informed consent form.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area) Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.