Effect of Probiotics on Pre-diabetes and Diabetes in China
1 other identifier
interventional
220
1 country
1
Brief Summary
This study is aimed at verifying the effects of probiotics (KAWAI:dead S.thermophilus) on glucos management among T2DM and pre-diabetes Chinese adult. Additionally, the investigators intend to verify the effects of probiotics on modifying the structure and function of gut microbiome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes-mellitus
Started Dec 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2017
CompletedFirst Posted
Study publicly available on registry
December 19, 2017
CompletedStudy Start
First participant enrolled
December 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedDecember 19, 2017
December 1, 2017
1 year
December 10, 2017
December 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes of blood glucose and insulin sensitivity
blood glucose of fasting and 2 hours after OGTT，fasting insulin
3~5 years
Changes of gut microbiota composition
Feces gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis
3~5 years
Secondary Outcomes (3)
Changes of blood inflammatory markers
3~5 years
Composite changes in diabetes risk factors
3~5 years
Composite changes of weight, waist circumference and BMI
3~5 years
Other Outcomes (1)
Changes of Intestinal endocrine function
3~5 years
Study Arms (4)
probiotics on type 2 diabetes
EXPERIMENTALtake probiotics
probiotics on pre-diabetes
EXPERIMENTALtake probiotics
placebo on type 2 diabetes
PLACEBO COMPARATORtake placebo
placebo on pre-diabetes
PLACEBO COMPARATORtake placebo
Interventions
the probiotics group was taking probiotics 4 packets a day
the placebo group was taking placebo 4 packets a day
Eligibility Criteria
You may qualify if:
- Meet Diabetes/pre-diabetes diagnostic criteria
- BMI 18-35kg/m2
You may not qualify if:
- Patients with diabetes or hyperlipidemia, and need regular use of drugs.
- Secondary obesity or diabetes
- Digestive, tumor, heart, lung, kidney, rheumatic immunity and other systemic serious diseases
- Pregnant women, women ready for pregnancy, and nursing mothers
- Take antibiotics or bacterial agents within 1 month
- Diarrhea or abscess in 1 month or blood or other abnormal feces
- Diabetics have a history of more than 2 years
- The OGTT experiment of diabetic patients FG≥9mmol/L or 2h≥14mmol/L
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
health management center,Southwest hospital
Chongqing, Chongqing Municipality, 400030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qiang Zeng, MD
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Health Management Institue
Study Record Dates
First Submitted
December 10, 2017
First Posted
December 19, 2017
Study Start
December 21, 2017
Primary Completion
December 31, 2018
Study Completion
August 31, 2019
Last Updated
December 19, 2017
Record last verified: 2017-12