| Trial registration number
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NCT04756466 |
Full text link
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04756466
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First author
Last imported at : March 7, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Mónica Olivares
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Contact
Last imported at : March 7, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Ruth Blanco Rojo, rblanco@biosearchlife.com (PI email not reported)
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Registration date
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-02-16
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Recruitment status
Last imported at : March 14, 2023, midnight
Source : ClinicalTrials.gov
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Unknown
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Study design
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 7, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
person over 60 years of age.
intern in residence for the elderly.
sign informed consent.
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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person who at some previous time has tested positive for detection of covid-19 by pcr or serology.
person who at the time of starting the intervention presents symptoms compatible with covid-19.
person with concomitant disease type hiv, transplant, active cancer or other type of active immunosuppression.
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Number of arms
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Biosearch S.A.
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Inclusion age min
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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60
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Inclusion age max
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Spain
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Type of patients
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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High risk patients
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Severity scale
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : March 7, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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201
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primary outcome
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Incidence of SARS CoV-2 infection.
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Notes
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 707, "treatment_name": "Lactobacillus", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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