Effect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Diabetes-Related Outcomes in People With Type 1 Diabetes:a Single-blind Randomized Controlled Trial
Effect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Diabetes-Related Outcomes in People With Type 1 Diabetes:a Single-blind Randomized Controlled Trial
Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 1 diabetes is increasing. However, the effect of multistrain probiotics in people with type 1 diabetes remains unclear. This study investigated the effect of live combined Bifidobacterium and Lactobacillus preparation on glycemic control and other diabetes-related outcomes in people with type 1 diabetes.
Design A randomized, single-blind, parallel-group, controlled clinical trial. Setting Diabetes clinic of a teaching hospital in Shenzhen China Participants A total of 30 participants with type 1 diabetes, aged 18-60 years, will be recruited and randomly assigned to receive either probiotics (n = 15) or placebo (n = 15) for 12 weeks.
Outcomes Primary outcomes were glycemic control related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The gut microbiota profile will be analyzed before and after intervention and between groups.
Inclusion Criteria:
type 1 diabetes patients ,age 18-60years old,18 Kg/m2≤BMI≤30Kg/m2, 7.0mmol/L<fasting blood glucose <13.0mmol/L；HbA1c≤10%，ketonuria (-)；
Exclusion Criteria:
pregnancy, lactation, having other severe chronic illnesses.taking other anti-diabetic drugs