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

Phase 4

Completed

• Conditions: Type 1 Diabetes Mellitus; Probiotics
• Interventions: Drug: live combined Bifidobacterium and Lactobacillus Tablets

• Registration Number: NCT03556631
• Lead Sponsor: Shenzhen People's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-06-13
• Study First Posted: 2018-06-14
• Study Start: 2020-09-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotics group	live combined Bifidobacterium and Lactobacillus Tablets	live combined Bifidobacterium and Lactobacillus tablets were given to the participants according to their group assignment ,4 tablets ,tid, for 3 months
placebo group	live combined Bifidobacterium and Lactobacillus Tablets	placebo were given to the participants according to their group assignment ,4 tablets ,tid, for 3 months

Primary Outcome Measures

Name	Time	Method
hemoglobin A1c in percentage	3 months	analyze the change of hemoglobin A1c between two groups

Secondary Outcome Measures

Name	Time	Method
weight in kilograms	3 months	analyze the change of weight in kilograms between two groups

Trial Locations

Locations (1)

Shenzhen People' S Hospital; 🇨🇳 Shenzhen, China