Back to resultsEffect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Outcomes in Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus, Probiotics
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
live combined Bifidobacterium and Lactobacillus Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Shenzhen People' S Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
probiotics group
placebo group
Arm Description
live combined Bifidobacterium and Lactobacillus tablets were given to the participants according to their group assignment ,4 tablets ,tid, for 3 months
placebo were given to the participants according to their group assignment ,4 tablets ,tid, for 3 months
Outcomes
Primary Outcome Measures
hemoglobin A1c in percentage
analyze the change of hemoglobin A1c between two groups
Secondary Outcome Measures
weight in kilograms
analyze the change of weight in kilograms between two groups
Full Information
NCT ID
NCT03556631
First Posted
May 22, 2018
Last Updated
August 5, 2022
Sponsor
Shenzhen People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03556631
Brief Title
Effect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Outcomes in Type 1 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Probiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
probiotics group
Arm Type
Experimental
Arm Description
live combined Bifidobacterium and Lactobacillus tablets were given to the participants according to their group assignment ,4 tablets ,tid, for 3 months
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
placebo were given to the participants according to their group assignment ,4 tablets ,tid, for 3 months
Intervention Type
Drug
Intervention Name(s)
live combined Bifidobacterium and Lactobacillus Tablets
Other Intervention Name(s)
probiotics
Intervention Description
take the live combined Bifidobacterium and Lactobacillus Tablets 4# or placebo twice a day
Primary Outcome Measure Information:
Title
hemoglobin A1c in percentage
Description
analyze the change of hemoglobin A1c between two groups
Time Frame
3 months
Secondary Outcome Measure Information:
Title
weight in kilograms
Description
analyze the change of weight in kilograms between two groups
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Xu
Organizational Affiliation
associate chief physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenzhen People' S Hospital
City
Shenzhen
ZIP/Postal Code
518020
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Outcomes in Type 1 Diabetes
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