| Trial registration number
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NCT05195151 |
Full text link
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05195151
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First author
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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Jean-Charles Pasquier, Dr.
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Contact
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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jean-charles.pasquier@usherbrooke.ca
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Registration date
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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2022-01-18
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Recruitment status
Last imported at : Nov. 22, 2022, noon
Source : ClinicalTrials.gov
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Recruiting
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Study design
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Feb. 14, 2023, noon
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : May 24, 2022, 10:30 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
men and women, aged 65-89 years, who have received 3 doses of a mrna vaccine (pfizer-biontech or moderna) for more than 6 months, volunteered for a fourth dose of vaccine, had telephone or internet access, were able to provide informed consent, and lived <75 km from the crc (subgroup of 100 participants only)
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Exclusion criteria
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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patients with covid-19 disease (clinical and serological data at post), with possibly affected cognitive functions (score < 12 on the functional activities questionnaire (faq)), with allergies (soy, lactose, yeast, maltodextrin), with a chronically weakened immune system (aids...) or undergoing anti-cancer treatment (chemotherapy or radiotherapy) and who do not speak french or english.
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Number of arms
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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Université de Sherbrooke
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Inclusion age min
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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65
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Inclusion age max
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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89
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Countries
Last imported at : Nov. 22, 2022, noon
Source : ClinicalTrials.gov
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Canada
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Type of patients
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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Healthy volunteers
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Severity scale
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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668
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primary outcome
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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Decreasing of 33% the percentage of elders without Receptor-Binding Domain (RBD) antibodies, 6 months after the vaccine booster shot
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Notes
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Jan. 20, 2022, 11:30 a.m.
Source : ClinicalTrials.gov
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[{"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"}]
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