Evaluation of a Probiotic Supplementation in the Immune Response of Participants With COVID-19 (Coronavirus Disease).
Not Applicable
Completed
- Conditions
- Covid19
- Interventions
- Dietary Supplement: Placebo
- Registration Number
- NCT04937556
- Lead Sponsor
- ProbiSearch SL
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo supplement in 1 capsule per day during 28 days.
- Primary Outcome Measures
Name Time Method Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus. 1 month
- Secondary Outcome Measures
Name Time Method 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 Severity of symtoms will be analysed for fever (Tª\>38ºC) and gastrointestinal symptons (Bristol scale).
Percentage of participants with worsening of lower respiratory tract infections 1 month
Trial Locations
- Locations (1)
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain