|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02274272 |
|
Date of registration:
|
08/10/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effects of Genmont Probiotic on Improve the Level of Blood Glucose and Other Diabetic Associate Parameter in Type 2 Diabetes Patients
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
October 2014 |
|
Target sample size:
|
86 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02274272 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Taiwan
| | | | | | | |
|
Contacts
|
|
Name:
|
yi shing Chen, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
GenMont Biothech Incorporation |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Type 2 diabetes with a duration> 6 months
2. 7 % < HbA1c ? 10 %
3. Adults 25- 70 years of age
4. BMI>18.5
Exclusion Criteria:
1. Pregnancy
2. Subjects with any other serious diseases such as cancer (patient with benign tumor
under medical control should not be ruled out), kidney failure / dialysis, heart
disease, stroke.
3. Autoimmune Disease
4. Administration of other healthy food for diabetes 4 weeks before inclusion
5. Administration of probiotic 4 weeks before inclusion
6. Administration of antibiotics 4 weeks before inclusion
7. Participation in other clinical trials
8. ALT/SGPT or AST/SGOT > 3x upper limit of normal (ULN)
9. eGFR<30mL/min/1.73m2
10. Subjects who is lack of physical integrity of gastrointestinal tract, or malabsorption
syndrome, or inability to take oral medication.
Age minimum:
25 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Type 2 Diabetes
|
|
Intervention(s)
|
|
Other: GMNL-263
|
|
Other: placebo
|
|
Other: ADR-1
|
|
Primary Outcome(s)
|
|
Change in blood fat
[Time Frame: 6 months]
|
|
Change in blood sugar
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
Change in the DM marker
[Time Frame: 6 months]
|
|
Secondary ID(s)
|
|
P201404-31
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|