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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Lactulose oral solution
DrugOral, 30 mL once daily administered during breakfast.
Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules
DrugOral, 2 tablets (500 mg per tablet) three times daily (TID).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Lactulose Oral SolutionActive comparator 1 intervention
Group B: Lactulose Oral Solution+Live Combined B. Subtilis and E. Faecium Enteric-coated CapsulesExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Changes in Constipation Symptom Scores Pre- and Post-Treatment
Assessment of treatment efficacy on constipation symptoms: Changes in symptom scores from baseline to post-treatment within each treatment arm and comparative analysis between the lactulose monotherapy group and lactulose+Medilac-S combination therapy group
Time frame
From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment2
Changes in Fecal Microbiota Composition (16S rRNA and Metagenomics)
Comparison of Fecal Microbiota Composition Changes (16S rRNA and Metagenomics): Pre- vs. Post-Treatment Alterations and Intergroup Differences Between Lactulose Monotherapy and Lactulose+Medilac-S Combination Therapy
Time frame
From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment3
Temporal Changes in Fecal Untargeted Metabolomics Profiles
Temporal Changes in Fecal Untargeted Metabolomics Profiles: Pre- vs. post-treatment alterations and comparative analysis between lactulose monotherapy and lactulose+Medilac-S combination groups.
Time frame
From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatmentSecondary outcomes
1
Changes in Fasting Blood Glucose and Glycated Albumin Levels
Changes in Fasting Blood Glucose and Glycated Albumin Levels: Pre- vs. post-treatment variations and comparative analysis between lactulose monotherapy and lactulose+Medilac-S combination groups
Time frame
From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment2
Changes in Blood Lipid Profiles (Total Cholesterol, Triglycerides, HDL-C, and LDL-C)
Changes in Blood Lipid Profiles (Total Cholesterol, Triglycerides, HDL-C, and LDL-C): Pre- vs. post-treatment alterations and comparative analysis between lactulose monotherapy and lactulose+Medilac-S combination therapy groups
Time frame
From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking Union Medical College Hospital
Lead sponsor
Beijing Hospital
Collaborator
Beijing Huaxin Hospital
Collaborator
Beijing Luhe Hospital
Collaborator
Beijing Huairou Hospital
Collaborator
Source ClinicalTrials.gov