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

Covid19 Clinical Trial

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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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04937556
• Other study ID #: COV/21.02
• Status: Completed
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2022
• Source: ProbiSearch SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 30, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Infanta Leonor	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
ProbiSearch SL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus.		1 month
Secondary	Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood serum.		1 month
Secondary	Duration of the symptoms produced by the SARS-CoV-2 infection		1 month
Secondary	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
Secondary	Percentage of participants with a negative result in the SARS-CoV-2 detection test by PCR (Polymerase Chain Reaction) at visit 2		1 month
Secondary	Percentage of participants with worsening of lower respiratory tract infections		1 month

External Links

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