Effect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Outcomes in Type 1 Diabetes

Southern University of Science and Technology

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes Mellitus; Probiotics

Treatments: Drug: live combined Bifidobacterium and Lactobacillus Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT03556631

SZLY2018009

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

probiotics group

Experimental group

Description:

live combined Bifidobacterium and Lactobacillus tablets were given to the participants according to their group assignment ,4 tablets ,tid, for 3 months

Treatment:

Drug: live combined Bifidobacterium and Lactobacillus Tablets

placebo group

Placebo Comparator group

Description:

placebo were given to the participants according to their group assignment ,4 tablets ,tid, for 3 months

Treatment:

Drug: live combined Bifidobacterium and Lactobacillus Tablets