RecruitingNot ApplicableNCT07065942

Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients


Sponsor

Peking Union Medical College Hospital

Enrollment

60 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Constipation is the most common gastrointestinal manifestation in diabetic patients. Emerging evidence suggests that gut microbiota dysbiosis may contribute to the pathogenesis of diabetes, highlighting the need to investigate its role in diabetic constipation, though current research remains limited. Current management of diabetic constipation primarily relies on bulk-forming and osmotic laxatives. Additionally, microbiome-modulating agents (e.g., probiotics, prebiotics, and synbiotics) may serve as adjunctive therapies by regulating gut microbiota and enhancing intestinal motility. Lactulose, a well-tolerated osmotic laxative with prebiotic effects, is widely recommended in clinical guidelines. It promotes short-chain fatty acid production, increases fecal volume, and accelerates colonic transit, thereby alleviating constipation. However, its specific impact on gut microbiota composition and metabolic pathways in diabetic constipation remains unclear. This study aims to explore changes in fecal microbiota and metabolomic profiles in diabetic patients with chronic constipation following treatment with lactulose alone or in combination with Bacillus subtilis-Enterococcus faecium probiotics, providing mechanistic insights into prebiotic therapy for this condition.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lactulose oral solution and a drug called Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules for people with constipation - functional and diabetes mellitus. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLactulose oral solution

Oral, 30 mL once daily administered during breakfast.

DRUGLive Combined B. Subtilis and E. Faecium Enteric-coated Capsules

Oral, 2 tablets (500 mg per tablet) three times daily (TID).


Locations(1)

Peking Union Medical College Hospital

Beijing, China

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NCT07065942


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