Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in Constipation Symptom Scores Pre- and Post-Treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-70 years
- •Type 2 Diabetes Diagnosis (per 2017 ADA criteria), meeting ≥1 of:
- •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
- •Functional Constipation (Rome IV criteria), requiring:
- •≥2 of the following
- •occurring in ≥25% of defecations
- •Lumpy/hard stools (Bristol Stool Scale 1-2)
- •Sensation of incomplete evacuation
- •Anorectal obstruction/blockage
- •Manual maneuvers required
- •<3 spontaneous bowel movements/week
- •No loose stools without laxatives
- •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
排除标准
- •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:
- •Cardiopulmonary insufficiency
- •Cerebrovascular diseases
- •Psychiatric disorders
- •Recent use (within 1 month) of confounding medications:
- •Probiotics/prebiotics
- •Antibiotics
- •Laxatives (e.g., osmotic/stimulant agents)
- •Prokinetics
研究组 & 干预措施
Lactulose Oral Solution
干预措施: Lactulose oral solution (Drug)
Lactulose Oral Solution+Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules
干预措施: Lactulose oral solution (Drug)
Lactulose Oral Solution+Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules
干预措施: Live Combined B. Subtilis and E. Faecium Enteric-coated Capsules (Drug)
结局指标
主要结局
Changes in Constipation Symptom Scores Pre- and Post-Treatment
时间窗: From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of 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
Changes in Fecal Microbiota Composition (16S rRNA and Metagenomics)
时间窗: From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment
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
Temporal Changes in Fecal Untargeted Metabolomics Profiles
时间窗: From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment
Temporal Changes in Fecal Untargeted Metabolomics Profiles: Pre- vs. post-treatment alterations and comparative analysis between lactulose monotherapy and lactulose+Medilac-S combination groups.
次要结局
- Changes in Fasting Blood Glucose and Glycated Albumin Levels(From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment)
- Changes in Blood Lipid Profiles (Total Cholesterol, Triglycerides, HDL-C, and LDL-C)(From enrollment (0 week) to 2 weeks, and 4 Weeks at the end of treatment)
研究者
Jing-Nan Li
Chief physician, Professor
Peking Union Medical College Hospital