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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Probiotic: Lactobacillus salivarius + Vit D + Zinc
Placebo
Sponsored by
ProbiSearch SL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Infanta Leonor

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic: Lactobacillus salivarius + Vit D + Zinc

Placebo

Arm Description

Lactobacillus strain during 28 days, approximately 1*10E9 colony forming unit (CFU) of L. salivarius in 1 capsule per day.

Placebo supplement in 1 capsule per day during 28 days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood serum.
Duration of the symptoms produced by the SARS-CoV-2 infection
Severity of symptoms produced during SARS-CoV-2 infection
Severity of symtoms will be analysed for fever (Tª>38ºC) and gastrointestinal symptons (Bristol scale).
Percentage of participants with a negative result in the SARS-CoV-2 detection test by PCR (Polymerase Chain Reaction) at visit 2
Percentage of participants with worsening of lower respiratory tract infections

Full Information

First Posted
June 14, 2021
Last Updated
May 27, 2022
Sponsor
ProbiSearch SL
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1. Study Identification

Unique Protocol Identification Number
NCT04937556
Brief Title
Evaluation of a Probiotic Supplementation in the Immune Response of Participants With COVID-19 (Coronavirus Disease).
Acronym
PROVID
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProbiSearch SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic: Lactobacillus salivarius + Vit D + Zinc
Arm Type
Active Comparator
Arm Description
Lactobacillus strain during 28 days, approximately 1*10E9 colony forming unit (CFU) of L. salivarius in 1 capsule per day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo supplement in 1 capsule per day during 28 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic: Lactobacillus salivarius + Vit D + Zinc
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo in 1 capsule will be daily administrated during 28 days.
Primary Outcome Measure Information:
Title
Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood serum.
Time Frame
1 month
Title
Duration of the symptoms produced by the SARS-CoV-2 infection
Time Frame
1 month
Title
Severity of symptoms produced during SARS-CoV-2 infection
Description
Severity of symtoms will be analysed for fever (Tª>38ºC) and gastrointestinal symptons (Bristol scale).
Time Frame
1 month
Title
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
Title
Percentage of participants with worsening of lower respiratory tract infections
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.probisearch.com
Description
Related Info

Learn more about this trial

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

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