Ignite Creation Date:
2024-05-06 @ 4:26 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04982380
Status:
UNKNOWN
Last Update Posted:
2021-07-29
First Post:
2021-07-23
Brief Title:
Efficacy and Safety of Bifidobacterium Quadruple Live Tablets in Patients With T2DM and Constipation
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
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
Status Verified Date:
2021-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None