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

Sponsor
ProbiSearch SL (Industry)
Overall Status
Completed
CT.gov ID
NCT04937556
Collaborator
(none)
41
Enrollment
1
Location
2
Arms
6.1
Actual Duration (Months)
6.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic: Lactobacillus salivarius + Vit D + Zinc
  • Dietary Supplement: Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Oct 25, 2021
Actual Primary Completion Date :
Mar 25, 2022
Actual Study Completion Date :
Apr 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

  2. Duration of the symptoms produced by the SARS-CoV-2 infection [1 month]

  3. 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).

  4. Percentage of participants with a negative result in the SARS-CoV-2 detection test by PCR (Polymerase Chain Reaction) at visit 2 [1 month]

  5. Percentage of participants with worsening of lower respiratory tract infections [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario Infanta Leonor Madrid Spain

Sponsors and Collaborators

  • ProbiSearch SL

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
ProbiSearch SL
ClinicalTrials.gov Identifier:
NCT04937556
Other Study ID Numbers:
  • COV/21.02
First Posted:
Jun 24, 2021
Last Update Posted:
May 31, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of May 31, 2022