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

RecruitingNAAges 18 Years - 70 YearsAllPeking Union Medical College Hospital
NCT07065942 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 composit

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age: 18-70 years * Type 2 Diabetes Diagnosis (per 2017 ADA criteria), meeting ≥1 of: 1. Fasting plasma glucose (FPG) ≥7.0 mmol/L 2. hour plasma glucose ≥11.1 mmol/L during 75g anhydrous oral glucose tolerance test (OGTT) 3. Random plasma glucose ≥11.1 mmol/L with hyperglycemia symptoms or hyperglycemic crisis * Functional Constipation (Rome IV criteria), requiring: 1. ≥2 of the following 1. occurring in ≥25% of defecations 2. Straining 3. Lumpy/hard stools (Bristol Stool Scale 1-2) 4. Sensation of incomplete evacuation 5. Anorectal obstruction/blockage 6. Manual maneuvers required 7. \<3 spontaneous bowel movements/week 2. No loose stools without laxatives 3. Exclusion of IBS diagnosis. Symptom duration \>6 months, with active symptoms meeting criteria for last 3 months. * Stable Glycemic Control: No anticipated antidiabetic medication adjustments during study * Dietary Stability: Maintain consistent diet; avoid yogurt, fermented foods, prebiotic-containing processed foods, or other items that may confound results Exclusion Criteria: * 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. * Severe chronic comorbidities, including: 1. Cardiopulmonary insufficiency 2. Cerebrovascular diseases 3. Psychiatric disorders * Recent use (within 1 month) of confounding medications: 1. Probiotics/prebiotics 2. Antibiotics 3. Laxatives (e.g., osmotic/stimulant agents) 4. Prokinetics
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What it tests

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

1 site
Peking Union Medical College Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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