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Type II Diabetes MellitusNCT07084350

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

A study testing lactulose and PEG (solution given 4 L) in people with Type II Diabetes Mellitus, run by General Hospital of Shenyang Military Region at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type II Diabetes Mellitus
What is being tested?
lactulose and PEG (solution given 4 L)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
4 Sep 2025to 18 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Shenyang, Liaoning, 110840

Other trials in China

About this study

Official 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

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.

Read the detailed description

Overall, 300 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.).

Being tested
lactulose, PEG (solution given 4 L)
Keywords
Type II diabetes mellitus, Bowel preparation, Lactulose, Polyethylene glycol
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lactuloseDrug

    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.

Study groups in NCT07084350
Study groupRoleWhat they receive
Lac+PEG-ELS groupExperimentalOral lactulose combined with PEG-ELS
Receives: Drug: lactulose; Drug: PEG (solution given 4 L)
PEG-ELS groupActive comparatorOnly PEG-ELS
Receives: Drug: PEG (solution given 4 L)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adequate Bowel Preparation Rate

    Measured: 3 days

Secondary outcomes (3)

  1. Excellent Bowel Preparation Rate

    Measured: 3 days

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

    Measured: 3 days

  3. Adverse reactions rate associated with bowel preparation

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2025
  2. Study start4 Sep 2025
  3. Primary completion18 May 2026
  4. Study completion18 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07084350
Sponsor's protocol ID
XHNKKY-OLPG
Status last verified
Jul 2026
First submitted
17 Jul 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.

    PubMed 19136102

  • American Diabetes Association Professional Practice Committee. 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S27-S49. doi: 10.2337/dc25-S002.

    PubMed 39651986

  • Zhang X, Chen Y, Chen Y, Zhu W, Tang C, Lamm S, Li L. Polyethylene glycol combined with lactulose has better efficacy than polyethylene glycol alone in bowel preparation before colonoscopy: A meta-analysis. Clinics (Sao Paulo). 2023 Apr 3;78:100172. doi: 10.1016/j.clinsp.2023.100172. eCollection 2023.

    PubMed 37019039

  • He Y, Liu Q, Chen YW, Cui LJ, Cao K, Guo ZH. Bowel preparation protocol for hospitalized patients ages 50 years or older: A randomized controlled trial. World J Gastrointest Endosc. 2024 Jan 16;16(1):18-28. doi: 10.4253/wjge.v16.i1.18.

    PubMed 38313462

  • Yuanchao H, Xueping L, Tao L, Jianping N, Man M. The advantage of polyethylene glycol electrolyte solution combined with lactulose in patients with long interval preparation-to-colonoscopy. Turk J Gastroenterol. 2020 Jan;31(1):23-29. doi: 10.5152/tjg.2020.18888.

    PubMed 32009610

  • Ramos JA, Carvalho D, Arantes VN. Novel regimen for colonoscopy bowel preparation with oral lactulose: a prospective comparative study. Clin Endosc. 2024 Nov;57(6):775-782. doi: 10.5946/ce.2024.056. Epub 2024 Oct 22.

    PubMed 39434557

  • Li CX, Guo Y, Zhu YJ, Zhu JR, Xiao QS, Chen DF, Lan CH. Comparison of Polyethylene Glycol versus Lactulose Oral Solution for Bowel Preparation prior to Colonoscopy. Gastroenterol Res Pract. 2019 Apr 11;2019:2651450. doi: 10.1155/2019/2651450. eCollection 2019.

    PubMed 31097959

  • Lu J, Cao Q, Wang X, Pu J, Peng X. Application of Oral Lactulose in Combination With Polyethylene Glycol Electrolyte Powder for Colonoscopy Bowel Preparation in Patients With Constipation. Am J Ther. 2016 Jul-Aug;23(4):e1020-4. doi: 10.1097/MJT.0000000000000351.

    PubMed 26658804

  • Pieber TR, Svehlikova E, Mursic I, Esterl T, Wargenau M, Sartorius T, Pauly L, Schwejda-Guettes S, Neumann A, Faerber V, Stover JF, Gaigg B, Kuchinka-Koch A. Blood glucose response after oral lactulose intake in type 2 diabetic individuals. World J Diabetes. 2021 Jun 15;12(6):893-907. doi: 10.4239/wjd.v12.i6.893.

    PubMed 34168736

  • Chung YW, Han DS, Park KH, Kim KO, Park CH, Hahn T, Yoo KS, Park SH, Kim JH, Park CK. Patient factors predictive of inadequate bowel preparation using polyethylene glycol: a prospective study in Korea. J Clin Gastroenterol. 2009 May-Jun;43(5):448-52. doi: 10.1097/MCG.0b013e3181662442.

    PubMed 18978506

  • Hassan C, East J, Radaelli F, Spada C, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Fuccio L, Awadie H, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Vanella G, Mangas-Sanjuan C, Frazzoni L, Van Hooft JE, Dumonceau JM. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019 Aug;51(8):775-794. doi: 10.1055/a-0959-0505. Epub 2019 Jul 11.

    PubMed 31295746

  • Hochberg I, Segol O, Shental R, Shimoni P, Eldor R. Antihyperglycemic therapy during colonoscopy preparation: A review and suggestions for practical recommendations. United European Gastroenterol J. 2019 Jul;7(6):735-740. doi: 10.1177/2050640619846365. Epub 2019 Apr 20.

    PubMed 31316777

  • Alvarez-Gonzalez MA, Flores-Le Roux JA, Seoane A, Pedro-Botet J, Carot L, Fernandez-Clotet A, Raga A, Pantaleon MA, Barranco L, Bory F, Lorenzo-Zuniga V. Efficacy of a multifactorial strategy for bowel preparation in diabetic patients undergoing colonoscopy: a randomized trial. Endoscopy. 2016 Nov;48(11):1003-1009. doi: 10.1055/s-0042-111320. Epub 2016 Aug 4.

    PubMed 27490086

  • Prasad VG, Abraham P. Management of chronic constipation in patients with diabetes mellitus. Indian J Gastroenterol. 2017 Jan;36(1):11-22. doi: 10.1007/s12664-016-0724-2. Epub 2016 Dec 17.

    PubMed 27987136

  • Chandrasekharan B, Anitha M, Blatt R, Shahnavaz N, Kooby D, Staley C, Mwangi S, Jones DP, Sitaraman SV, Srinivasan S. Colonic motor dysfunction in human diabetes is associated with enteric neuronal loss and increased oxidative stress. Neurogastroenterol Motil. 2011 Feb;23(2):131-8, e26. doi: 10.1111/j.1365-2982.2010.01611.x. Epub 2010 Oct 12.

    PubMed 20939847

Questions about this trial

What is this clinical trial studying?

A study testing lactulose and PEG (solution given 4 L) in people with Type II Diabetes Mellitus, run by General Hospital of Shenyang Military Region at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adequate Bowel Preparation Rate (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07084350, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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