NCT04937556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

May 31, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

June 14, 2021

Last Update Submit

May 27, 2022

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

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

    1 month

Secondary Outcomes (5)

  • 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

    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

Study Arms (2)

Probiotic: Lactobacillus salivarius + Vit D + Zinc

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Placebo supplement in 1 capsule per day during 28 days.

Dietary Supplement: Placebo

Interventions

Probiotic: Lactobacillus salivarius + Vit D + ZincDIETARY_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.

Probiotic: Lactobacillus salivarius + Vit D + Zinc
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (18-65 years).
  • Mild infection by SARS-CoV-2 detected by PCR or Antigen.
  • Signed written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Infanta Leonor

Madrid, Spain

Location

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

Zinc

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 24, 2021

Study Start

October 25, 2021

Primary Completion

March 25, 2022

Study Completion

April 30, 2022

Last Updated

May 31, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)