Effect of Live Combined Bifidobacterium and Lactobacillus on Glycemic Control and Other Outcomes in Type 1 Diabetes
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 14, 2018
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2021
CompletedAugust 9, 2022
August 1, 2022
1.1 years
May 22, 2018
August 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
hemoglobin A1c in percentage
analyze the change of hemoglobin A1c between two groups
3 months
Secondary Outcomes (1)
weight in kilograms
3 months
Study Arms (2)
probiotics group
EXPERIMENTALlive combined Bifidobacterium and Lactobacillus tablets were given to the participants according to their group assignment ,4 tablets ,tid, for 3 months
placebo group
PLACEBO COMPARATORplacebo were given to the participants according to their group assignment ,4 tablets ,tid, for 3 months
Interventions
take the live combined Bifidobacterium and Lactobacillus Tablets 4# or placebo twice a day
Eligibility Criteria
You may qualify if:
- 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 (-)；
You may not qualify if:
- pregnancy, lactation, having other severe chronic illnesses.taking other anti-diabetic drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shenzhen People' S Hospital
Shenzhen, 518020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ping Xu
associate chief physician
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 14, 2018
Study Start
September 1, 2020
Primary Completion
September 30, 2021
Study Completion
October 30, 2021
Last Updated
August 9, 2022
Record last verified: 2022-08