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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking Union Medical College Hospital

About this trial

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 criteria

Qualifiers

Age: 18-70 years

Fasting plasma glucose (FPG) ≥7.0 mmol/L

hour plasma glucose ≥11.1 mmol/L during 75g anhydrous oral glucose tolerance test (OGTT)

Random plasma glucose ≥11.1 mmol/L with hyperglycemia symptoms or hyperglycemic crisis

Disqualifiers

Secondary Constipation due to organic diseases or medication effects.

Constipation-predominant Irritable Bowel Syndrome (IBS-C).

Concurrent gastrointestinal disorders (e.g., inflammatory bowel disease, colorectal cancer).

Type 1 Diabetes Mellitus.

Trial design

Treatments tested in this trial

  • Lactulose oral solution
  • Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Peking Union Medical College Hospital

Lead sponsor

Beijing Hospital

Collaborator

Beijing Huaxin Hospital

Collaborator

Beijing Luhe Hospital

Collaborator

Beijing Huairou Hospital

Collaborator