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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
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.
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.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Number of bowel movements
Changes from baseline in the number of completely spontaneous bowel movements (CSBMs) and number of spontaneous bowel movements (SBMs). Effectiveness is defined as CSBMs more than 3 times weekly (including 3 times) with increase from baseline, while ineffectiveness is defined as CSBMs less than 3 times weekly or with no increase from baseline.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Glycosylated hemoglobin
Changes from baseline in glycosylated hemoglobin.
Time frame: Baseline, Week 12, Week 16
Glycosylated albumin
Changes from baseline in glycosylated albumin.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Gut micobiota
Changes from baseline in gut microbiota.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
The ratio of CSBMs to SBMs
Changes from baseline in the ratio of CSBMs to SBMs.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Bristol Stool Scale
Proportions whose stool characters recover to Type III and IV by Bristol Stool Scale.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Bowel Function Index (BFI)
Changes from baseline in the score of Bowel Function Index (BFI).
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Patient Assessment of Constipation symptom (PAC-SYM)
Changes from baseline in the scale of Patient Assessment of Constipation symptom (PAC-SYM).
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Patient global impression of changes (PGIC)
Difference in the Patient global impression of changes (PGIC) between experimental group and control group.
Time frame: Week 16
The first time of CSBM
Difference in the first time of completely spontaneous bowel movement (CSBM) between the experimental group and control group.
Time frame: Week 1 to Week 16
Fasting blood glucose
Changes from baseline in fasting blood glucose.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16
Serum lipid spectrum
Changes from baseline in serum lipid spectrum.
Time frame: Baseline, Week 12
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