Study of Lactulose Alone and With Probiotics on Gut Health and Constipation in Adults With Type 2 Diabetes

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.

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