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

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.

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 Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Dietary supplement: Probiotic: Lactobacillus salivarius + Vit D + Zinc; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Hospital Universitario Infanta Leonor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotic: Lactobacillus salivarius + Vit D + Zinc; Lactobacillus strain during 28 days, approximately 1*10E9 colony forming unit (CFU) of L. salivarius in 1 capsule per day.	Dietary supplement: Probiotic: Lactobacillus salivarius + Vit D + Zinc; 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 Comparator: Placebo; Placebo supplement in 1 capsule per day during 28 days.	Dietary supplement: Placebo; Placebo in 1 capsule will be daily administrated during 28 days.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood serum.		1 month
Duration of the symptoms produced by the SARS-CoV-2 infection		1 month
Severity of symptoms produced during SARS-CoV-2 infection	Severity of symtoms will be analysed for fever (Tª>38ºC) and gastrointestinal symptons (Bristol scale).	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
Percentage of participants with worsening of lower respiratory tract infections		1 month

Collaborators and Investigators

• Sponsor: ProbiSearch SL

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COV/21.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No