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OpenTrials
Completed

NCT Number: NCT04937556

Evaluation of a Probiotic Supplementation in the Immune Response of Participants With COVID-19 (Coronavirus Disease).

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Infanta Leonor

Madrid, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic: Lactobacillus salivarius + Vit D + Zinc

Dietary Supplement

A mixture of 1*10E9 colony forming unit (CFU) of Lactobacillus salivarius + Vit D + Zinc citrate in 1 capsule will be daily administrated during 28 days.

Placebo

Dietary Supplement

Placebo in 1 capsule will be daily administrated during 28 days.

Primary outcomes

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

    Time frame: 1 month

Secondary outcomes

  1. Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood serum.

    Time frame: 1 month

  2. Duration of the symptoms produced by the SARS-CoV-2 infection

    Time frame: 1 month

  3. Severity of symptoms produced during SARS-CoV-2 infection

    Time frame: 1 month

    Severity of symtoms will be analysed for fever (Tª>38ºC) and gastrointestinal symptons (Bristol scale).

  4. Percentage of participants with a negative result in the SARS-CoV-2 detection test by PCR (Polymerase Chain Reaction) at visit 2

    Time frame: 1 month

  5. Percentage of participants with worsening of lower respiratory tract infections

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

ProbiSearch SL

Industry

Registry information

Official study title

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.

Acronym: PROVID

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 24, 2021
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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