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Trial - NCT04937556


Column Value
Trial registration number NCT04937556
Full text link
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04937556

First author
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

2021-06-24

Recruitment status
Last imported at : June 1, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 26, 2021, 2 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 : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - adult (18-65 years). - mild infection by sars-cov-2 detected by pcr or antigen. - onset of covid-19 symptoms up to 5 days before the day of inclusion - without hospitalization or oxygen supplementation on the day of inclusion. - signed written informed consent

Exclusion criteria
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

- serious sars-cov-2 infection requiring hospitalization or oxygen supply - chronic diseases under regular medication (eg asthma, allergic rhinitis ...) - congenital or acquired immunodeficiency - body mass index (bmi)> 30 - coagulation disorders - short bowel syndrome or any surgery on the gastrointestinal tract. - metabolic disorders (diabetes, etc.). - heart failure and cardiac medical history - pregnant women. - hiv positive. - immunocompromised - history of significant gastrointestinal diseases - use of other probiotics during the last month. - uncertainty about the willingness or ability of the participant to comply with the requirements of the protocol.

Number of arms
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

ProbiSearch SL

Inclusion age min
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

65

Countries
Last imported at : Nov. 2, 2021, 12:30 p.m.
Source : ClinicalTrials.gov

Spain

Type of patients
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : June 26, 2021, 2 a.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : April 21, 2022, 1 a.m.
Source : ClinicalTrials.gov

41

primary outcome
Last imported at : July 21, 2021, 4 p.m.
Source : ClinicalTrials.gov

Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus.

Notes
Last imported at : June 26, 2021, 2 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 : July 21, 2021, 4 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1598, "treatment_name": "Lactobacillus salivarius+vitamin d+zinc", "treatment_type": "Microbiota intervention+vitamins and dietary supplements", "pharmacological_treatment": "Non pharmacological treatment+pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]