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Trial - NCT04793997


Column Value
Trial registration number NCT04793997
Full text link
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04793997

First author
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Sarah o Lebeer

Contact
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

sarah.lebeer@uantwerpen.be

Registration date
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-03-11

Recruitment status
Last imported at : June 5, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Suspended

Study design
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : March 13, 2021, 12:31 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 : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - patients in primary care with a positive sars-cov-2 test based on pcr - instructed during screening and agreed not to use other probiotic nutritional supplements outside of the study during the study period - sign the consent form

Exclusion criteria
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- antibiotic use at baseline and during the study - vaccinated against sars-cov-2 at start of the study (both for index patients and household members that participate) - pregnant women - history of use of probiotic supplements in the past two weeks - current diagnosis of cancer or immunosuppressive therapy within the past 6 months - acute and chronic infectious and inflammatory upper airway diseases (eg acute / chronic rhinosinusitis) - clinically significant bleeding disorder - any other medical condition that, in the principal investigator's opinion, warrants exclusion from the trial

Number of arms
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

University Hospital, Antwerp

Inclusion age min
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

65

Countries
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Belgium

Type of patients
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Close contacts to covid patients

Severity scale
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

150

primary outcome
Last imported at : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Change in severity of COVID-19 infection symptoms after using microbiome spray

Notes
Last imported at : March 13, 2021, 12:31 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 : March 13, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 706, "treatment_name": "Lactobacilli", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]