NCT03556631

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Shenzhen People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Type 1 Diabetes Mellitus
• Probiotics

Interventions

Type	Name	Description
DRUG	live combined Bifidobacterium and Lactobacillus Tablets	take the live combined Bifidobacterium and Lactobacillus Tablets 4# or placebo twice a day

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-09-30
• Completion: 2021-10-30
• First posted: 2018-06-14
• Last updated: 2022-08-09

Locations

1 site across 1 country: China