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

ProbiSearch

Status: Completed

Conditions: Covid19

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic: Lactobacillus salivarius + Vit D + Zinc

Study type: Interventional

Funder types: Industry

Identifiers

NCT04937556

COV/21.02

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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41 participants in 2 patient groups, including a placebo group

Probiotic: Lactobacillus salivarius + Vit D + Zinc

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Probiotic: Lactobacillus salivarius + Vit D + Zinc

Placebo

Placebo Comparator group

Description:

Placebo supplement in 1 capsule per day during 28 days.

Treatment:

Dietary Supplement: Placebo