NCT04982380

Efficacy and Safety of Bifidobacterium Quadruple Live Tablets in Patients With T2DM and Constipation

Efficacy and Safety of Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live (Siliankang) in Patients With Type 2 Diabetes and Constipation: a Randomized, Double-blind, Placebo-controlled, Multicenter Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a 16 week, 1:1 randomised, controlled, open label, two-arm, parallel-group trial evaluating efficacy and safety of Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live (Siliankang) in patients with type 2 diabetes and constipation. Patients will be randomized into experimental group or control group treated with Siliankang or placebo tablets respectively. Total trial duration for the individual subject will be approximately 16 weeks including screening, 12-weeks treatment and 4-weeks follow-up. Patients will attend at 2-week, 8-week, 12-week and 16-week throughout the trial taking physical examination, having blood test, collecting faecal specimen and completing the questionnaire of constipation under the direction of doctors.

Conditions

• Type 2 Diabetes Mellitus With Complication

Interventions

Type	Name	Description
DRUG	Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live	Patients will be instructed to continue current antidiabetic treatment, which should be kept unchanged throughout the trial, and start treatment with Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live (Siliankang) 3 tablets p.o. tid for 12 weeks.
DRUG	Siliankang simulating tablets	Patients will be instructed to continue current antidiabetic treatment, which should be kept unchanged throughout the trial, and start treatment with Siliankang simulative tablets 3 tablets p.o. tid for 12 weeks.

Timeline

• Start date: 2021-07-31
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2021-07-29
• Last updated: 2021-07-29

Locations

1 site across 1 country: China