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NCT03556631 Clinical Trial

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

Type 1 Diabetes Mellitus Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03556631
Other study ID # SZLY2018009
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 1, 2020
Est. completion date October 30, 2021

Study information
Verified date August 2022
Source Shenzhen People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date October 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• live combined Bifidobacterium and Lactobacillus Tablets
take the live combined Bifidobacterium and Lactobacillus Tablets 4# or placebo twice a day

Locations
Country Name City State
China Shenzhen People' S Hospital Shenzhen

Sponsors (1)
Lead Sponsor Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary hemoglobin A1c in percentage analyze the change of hemoglobin A1c between two groups 3 months
Secondary weight in kilograms analyze the change of weight in kilograms between two groups 3 months
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