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CompletedNCT04937556PROVIDUpdated May 31, 2022

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

An interventional study of Probiotic: Lactobacillus salivarius + Vit D + Zinc and Placebo in Covid19, sponsored by ProbiSearch SL. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-31.

Sponsored by ProbiSearch SL · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Covid19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 41 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

ProbiSearch SL is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
41 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Placebo

    Placebo supplement in 1 capsule per day during 28 days.

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementProbiotic: 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.

  • Dietary supplementPlacebo

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

06

What researchers measure

Primary outcomes

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

    Time frame: 1 month

Secondary outcomes

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

    Time frame: 1 month

  2. Duration of the symptoms produced by the SARS-CoV-2 infection

    Time frame: 1 month

  3. Severity of symptoms produced during SARS-CoV-2 infection

    Severity of symtoms will be analysed for fever (Tª\>38ºC) and gastrointestinal symptons (Bristol scale).

    Time frame: 1 month

  4. 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

  5. Percentage of participants with worsening of lower respiratory tract infections

    Time frame: 1 month

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Study locations

1 site
  • Hospital Universitario Infanta Leonor
    Madrid, Spain
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References and documents

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04937556
Lead sponsor
ProbiSearch SL
Responsible party
Sponsor
First posted
Jun 24, 2021
Start date
Oct 25, 2021
Primary completion
Mar 25, 2022
Completion
Apr 30, 2022
Last update
May 31, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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