NCT04937556CompletedNot Applicable
Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of the Lactobacillus Probiotic Strain in the Immune Response in Participants Positive for SARS-CoV-2 (Severe Acute Respiratory Syndrome-Coronavirus-2) Infection.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ProbiSearch SL
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus.
Study Overview
Brief Summary
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strain on the immune response in participants positive for SARS-CoV-2 infection.
The study duration will be 28 days, which includes 4 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Outcomes
Primary Outcomes
Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus.
Time Frame: 1 month
Secondary Outcomes
- Duration of the symptoms produced by the SARS-CoV-2 infection(1 month)
- Percentage of participants with a negative result in the SARS-CoV-2 detection test by PCR (Polymerase Chain Reaction) at visit 2(1 month)
- Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood serum.(1 month)
- Severity of symptoms produced during SARS-CoV-2 infection(1 month)
- Percentage of participants with worsening of lower respiratory tract infections(1 month)
Investigators
Study Sites (1)
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