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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04884776 |
|
Full text link
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Jan. 3, 2023, 2:57 p.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Jan. 3, 2023, 2:57 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2021-05-13 |
|
Recruitment status
Last imported at : Jan. 3, 2023, 2:57 p.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
substudy 1 inclusion criteria: age 18 years - below 65 years a confirmed diagnosis of type 2 dm for ≥ 3 months with stable control (i.e. no change in dm medications in recent 2 months) written informed consents obtained |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
known history of confirmed covid-19 infection known active sepsis or active malignancy known increased infection risk due to underlying immunosuppressed state which includes: prior organ or hematopoietic stem cell transplant neutropenia with absolute neutrophil count (anc) <500 cells/ul at the time of study inclusion known hiv infection with cd4 <200 cells/ul at the time of study inclusion on concomitant immunosuppressants or corticosteroid at a dose of prednisolone equivalent dose 10mg or more for more than 3 months known history or active infective endocarditis on peritoneal dialysis or haemodialysis documented pregnancy substudy 2 inclusion criteria: age 65 years and above written informed consents obtained |
|
Number of arms
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Chinese University of Hong Kong |
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Inclusion age min
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
65 |
|
Countries
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Hong Kong |
|
Type of patients
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
High risk patients |
|
Severity scale
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Jan. 3, 2023, 2:57 p.m. Source : ClinicalTrials.gov |
453 |
|
primary outcome
Last imported at : Jan. 3, 2023, 2:57 p.m. Source : ClinicalTrials.gov |
Adverse events/Serious adverse events |
|
Notes
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : May 15, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1022, "treatment_name": "Probiotics", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |