Actively Recruiting
Effects of Lactulose Alone or Combined with Probiotics on Gut Microbiota and Metabolism in Adults with Diabetic Constipation
Led by Peking Union Medical College Hospital · Updated on 2025-07-15
60
Participants Needed
1
Research Sites
N/A
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
Researchers are exploring how constipation, a common digestive issue in people with diabetes, may be linked to changes in gut bacteria. This study aims to understand the effects of lactulose, an osmotic laxative with prebiotic properties, alone or combined with probiotics (Bacillus subtilis and Enterococcus faecium), on gut bacteria and metabolism in diabetic patients with chronic constipation. The study seeks to provide new insights into how prebiotic treatments may help manage diabetic constipation. Participants will be randomly assigned to receive either lactulose oral solution once daily during breakfast or lactulose combined with probiotic capsules taken three times daily. The treatment period lasts four weeks, during which the study will monitor changes in constipation symptoms, gut microbiota composition, and metabolic profiles. These interventions are designed to evaluate the impact on gut health and diabetes-related digestive issues. During the study, participants will undergo assessments at the start, after two weeks, and at the end of four weeks. Researchers will measure constipation symptom scores, analyze fecal samples to study gut bacteria and metabolites, and monitor blood glucose and lipid levels. This comprehensive evaluation aims to understand how treatments affect digestive symptoms and metabolic health in diabetic patients. The study is sponsored by Peking Union Medical College Hospital and will continue until mid-2026.
CONDITIONS
Brief 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 mellitus according to 2017 ADA criteria
- Functional constipation diagnosed by Rome IV criteria with symptoms lasting over 6 months
- Stable blood sugar control without planned changes in diabetes medication during the study
- Maintain a consistent diet avoiding yogurt, fermented foods, and prebiotic-containing processed foods during the study period
You will not qualify if you...
- Constipation caused by organic diseases or medication effects
- Constipation-predominant irritable bowel syndrome (IBS-C)
- Other gastrointestinal diseases such as inflammatory bowel disease or colorectal cancer
- Diagnosis of type 1 diabetes mellitus
- Severe chronic conditions including heart or lung failure, cerebrovascular diseases, or psychiatric disorders
- Use of probiotics, prebiotics, antibiotics, laxatives, or prokinetic drugs within one month before the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive lactulose alone or combined with probiotics to evaluate effects on gut microbiota and metabolism.
Visits at enrollment, Week 2, and Week 4
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yaowen Hu
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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