Actively Recruiting
Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients
Led by Peking Union Medical College Hospital · Updated on 2025-07-15
60
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
B
Beijing Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Diagnosed with type 2 diabetes based on 2017 ADA criteria, meeting at least one of: fasting plasma glucose ≥7.0 mmol/L, 2-hour plasma glucose ≥11.1 mmol/L during 75g OGTT, or random plasma glucose ≥11.1 mmol/L with hyperglycemia symptoms
- Functional constipation as defined by Rome IV criteria, including at least two symptoms such as straining, hard stools, sensation of incomplete evacuation, anorectal blockage, manual maneuvers, or fewer than 3 bowel movements per week
- No loose stools without laxative use
- No diagnosis of irritable bowel syndrome
- Constipation symptoms lasting more than 6 months with active symptoms in the last 3 months
- Stable glycemic control with no expected changes in antidiabetic medication
- Consistent diet avoiding yogurt, fermented foods, prebiotic-containing processed foods, or other confounding items
You will not qualify if you...
- Constipation caused by organic diseases or medication effects
- Constipation-predominant irritable bowel syndrome (IBS-C)
- Other gastrointestinal disorders such as inflammatory bowel disease or colorectal cancer
- Diagnosis of type 1 diabetes mellitus
- Severe chronic conditions including cardiopulmonary insufficiency, cerebrovascular diseases, or psychiatric disorders
- Use within 1 month prior to the study of probiotics, prebiotics, antibiotics, laxatives, or prokinetic medications
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yaowen Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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