Efficacy and Safety of Bifidobacterium Quadruple Live Tablets in Patients With T2DM and Constipation
Status:
Not yet recruiting
Trial end date:
2022-07-31
Target enrollment:
Participant gender:
Summary
Constipation is one of the common complication of diabetes mellitus, whose pathogenesis was
previously recognized as decreased gastrointestinal motility caused by diabetic autonomic
neuropathy. It is always treated with gastrointestinal motility drugs or laxatives which may
have side effects such as gut microbiota dysbiosis and withdraw symptoms. Recently,
researches have indicated that the risk of developing type 2 diabetes mellitus is associated
with alterations in the structure of the gut microbiota and have begun to treat diabetic
constipation by improving gut microbiota of these patients. The rational use of
microecological preparation for the prevention and treatment of diabetic constipation has
received increasing attention. This trial is aimed to evaluate the efficacy and safety of
Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live
(Siliankang) in the treatment of patients with type 2 diabetes and constipation, and to
analyze its influence on gut microbiota and blood glucose.
Phase:
Phase 4
Details
Lead Sponsor:
Peking Union Medical College Hospital
Collaborators:
Affiliated Hospital of Chengde Medical University Chinese Academy of Sciences First Affiliated Hospital of Harbin Medical University Hangzhou Grand Biologic Pharmaceutical, Inc. The Affiliated Hospital of Inner Mongolia Medical University The First Affiliated Hospital of Zhengzhou University