MedDataX Logo

Efficacy of Probiotics in Reducing Duration and Symptoms of COVID-19

NCT ID: NCT04621071

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-12

Study Completion Date

2021-10-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

COVID-19 disease caused by a new coronavirus (SARS-CoV-2) has received worldwide attention. No specific antiviral treatment is recommended for COVID-19 and no vaccine is currently available. Probiotics may be considered as an option of treatment since they have anti-viral effect, trigger immunomodulation and have low side-effects.

This randomized controlled trial aims to evaluate the efficacy of probiotics to reduce the duration and symptoms of COVID-19 in a symptomatic population tested positive to SARS-CoV-2, self-caring at home.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Rational: COVID-19 disease is caused by a new coronavirus (SARS-CoV-2) and has received worldwide attention. No specific antiviral treatment is recommended for COVID-19 and no vaccine is currently available so far. Several strong arguments support the study of probiotics for COVID-19: 1) probiotics act on viruses by various well described mechanisms (reduction of absorption, cellular internalization of the virus, production of metabolites / substances having a direct antiviral effect; and immunomodulation); 2) probiotics are considered with a high level of evidence (meta-analysis) to reduce diarrhea (associated with antibiotics and Clostridium difficile) and for respiratory tract infections; 3) probiotics are affordable and available with low side-effects.

Objectives:

1. Evaluate the effect of probiotics on the duration of COVID-19 in symptomatic patients, with moderate forms of the disease.
2. Evaluate the effect of probiotics on the severity of COVID-19 in symptomatic patients, with moderate forms of the disease.
3. Evaluate the effect of probiotics on the evolution of oral and fecal microbiota in symptomatic patients, with moderate forms of the COVID-19 disease.

Population: Men and women, 18 years or older, with a first positive test for COVID-19 in the last 5 days, having symptoms of the COVID-19, self-caring at home, living in Quebec for the next 60 days, able to take medication alone, with access to a phone or to the Internet.

Material: After providing consent remotely (electronic or recorded by phone), patients will receive by mail at home: : a leaflet explaining the study, the study product (probiotics or placebo) for 25 days, a container of maple syrup and a cup, a thermometer, an oximeter, a logbook, 2 saliva sample self-collection kits, 2 stool sample self-collection kits and instruction sheets.

Randomization: Patients will be randomized in one of the study groups (stratified by age and gender). The randomization is double-blind and uses a ratio 1:1. Group A: will take probiotics for up to 25 days / Group B: will take placebo for up to 25 days.

Follow-up: Upon inclusion in the study, the participant will complete a questionnaire that will focus on socio-demographic (age, marital status), medical (weight, height, general health, current medication, symptoms…), food intake and other relevant information. The participants will fill a daily booklet evaluating their symptoms, compliance to treatment, medication intake, temperature, oxygen saturation value, etc. For those who will be admitted to hospital, data on their admission, complications and treatments will be collected. At 55 days after their enrollment, will fill an end of study questionnaire (symptoms, satisfaction, well-being, etc.).

Samples: The study includes the optional collection of saliva and stool samples twice, on Day 1 (before the first product is taken) and on Day 10.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

covid sars-cov-2 coronavirus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probiotics

Two probiotic strains will constitute the experimental arm (Probiotics). Patients will take two capsules a day (one closed capsule to swallow and one open capsule mixed with maple syrup) from Day 1 to Day 10 and one closed capsule to swallow from Day 11 to Day 25.They will stop the treatment if they are admitted to the hospital. The treatment will last a maximum of 25 days.

Group Type EXPERIMENTAL

Probiotics (2 strains 10x10^9 UFC)

Intervention Type DIETARY_SUPPLEMENT

Probiotic vs Placebo (1:1)

Placebo

Potato starch and magnesium stearate will constitute the comparator arm (Placebo). Patients will take two capsules a day (one closed capsule to swallow and one open capsule mixed with maple syrup) from Day 1 to Day 10 and one closed capsule to swallow from Day 11 to Day 25.They will stop the treatment if they are admitted to the hospital. The treatment will last a maximum of 25 days.

Group Type PLACEBO_COMPARATOR

Placebo (potato starch and magnesium stearate)

Intervention Type DIETARY_SUPPLEMENT

Probiotic vs Placebo (1:1)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Probiotics (2 strains 10x10^9 UFC)

Probiotic vs Placebo (1:1)

Intervention Type DIETARY_SUPPLEMENT

Placebo (potato starch and magnesium stearate)

Probiotic vs Placebo (1:1)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* First positive test for COVID-19 in the last 5 days;
* Having symptoms of the COVID-19 at enrollment;
* Self-caring at home;
* Living in Quebec for the next 60 days;
* Able to take medication alone;
* With access to a phone or to the Internet;
* Able to give informed consent.

Exclusion Criteria

* Taking probiotic supplements at enrollment;
* Taking antibiotics for a reason other than COVID-19 at enrollment;
* Allergies to soy, lactose, yeast, maltodextrin, vitamin C, potato starch, magnesium stearate, hypromellose or titanium dioxide;
* Has a chronically weakened immune system (AIDS, lymphoma, chemo-radio- corticosteroid therapy, immunosuppressive pathology);
* Was treated with chemo-radio-corticosteroid therapy in the last 6 months;
* Has active cancer;
* Taking immunosuppressive drugs (e.g. anti-rejection treatment after organ transplant);
* Already participating in another clinical trial;
* Is pregnant, expects to become pregnant in the next few months or is breastfeeding;
* Has any other condition that would prevent safe participation in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lallemand Health Solutions

INDUSTRY

Sponsor Role collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Charles Pasquier, Dr

Role: PRINCIPAL_INVESTIGATOR

CIUSSSE-CHUS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CIUSSS de L'Estrie-CHUS Hospital

Sherbrooke, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-3700

Identifier Type: -

Identifier Source: org_study_id