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Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients
Sponsor: Peking Union Medical College Hospital
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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-07-01
Completion Date
2026-07-30
Last Updated
2025-07-15
Healthy Volunteers
No
Interventions
Lactulose oral solution
Oral, 30 mL once daily administered during breakfast.
Live 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