The primary objective of the PROVID-LD study is to evaluate the effect of probiotics on the duration and severity of COVID-19 in symptomatic patients, with moderate forms of the disease and in self-isolation.

A clinical study, or trial, is a research study that evaluates new ways to prevent, detect, treat or manage a disease.

Clinical trials move medical knowledge forward in multiple ways: Some trials work on scientific questions that help us better understand the disease, others help discover the most efficient treatment for infected patients.

All participation in a clinical trial is done on a voluntary basis.

In a clinical trial, the efficacy of the investigational product is often compared with a commonly used treatment. In a situation where there is no current treatment (as for COVID-19), the investigational product is compared to a placebo.

We randomly divide patients into two different groups so that they have the same characteristics and they can be compared (randomized trial). Following this, one group will receive the investigational product (probiotics) and the other group will receive an identical product without the active ingredient (placebo). It will not be possible to tell the difference between the probiotic and the placebo. The placebo in this study is similar to starch.

During the study
Throughout the study, neither the patients, the physicians or the research team staff will know which patients have received the investigational product or the placebo. It is a double-blind trial. Both groups are monitored in the same way.

At the end of the study
At the end of the study, we will compare the results from the two groups. If the results of the probiotics group are better than those of the placebo group, we will conclude that probiotics are more effective than the placebo. Initially, the groups are comparable, their only difference is taking the probiotic or the placebo; thus it is possible to infer a causal relationship and validate or not that probiotics have an effect on COVID-19.

The WHO defines probiotics as “live microorganisms which when administered in adequate amounts confer a health benefit on the host.”
Probiotics’ effect on health is a controversial subject in the scientific community.

Evidence has shown that probiotics are effective in reducing antibiotic-associated diarrhea, Clostridium difficile-associated diarrhea and respiratory tract infections. In other areas, it is impossible to validate probiotics’ efficacy with the same amount of evidence. Hence the need for this study.

A placebo is a medical treatment or procedure that does not contain any active ingredients. Therefore it does have a pharmacological impact on the pathology that is treated. This being said, placebos are known to have beneficial psychological and physiological effects.

Therefore, in the pursuit of this study, we are seeking to assess whether or not probiotics will produce an greater reduction in COVID symptoms and subsequent long COVID cases, over that of the placebo.

The placebo is a neutral substance that is not absorbed by your body. One will not be able to tell the probiotic capsule apart from the placebo.

Risks associated with taking probiotics are very small and there is no warning of potential risk from Health Canada. However, there may be risks with probiotics that are still undocumented.

Although probiotics are safe for most people, since patients with a weakened immune system must avoid them, immunocompromised patients will be excluded from the PROVID-LD study.

Respecting the dosage
To mitigate the risks associated with taking probiotics, it is important to take the recommended dose based on well-documented data.

The details about dosage are listed in the Steps of study page. The initial daily dose will be 2 capsules. The second stage will only require taking one capsule/day.

Respecting the dosage
To mitigate the risks associated with taking probiotics, it is important to take the recommended dose based on well-documented data.

Probiotics are used as drugs or nutritional supplements to a large extent. Some people may experience intestinal discomfort (bloating, gas, loose stool).

You will have regular follow-ups throughout the clinical trial.

You will contribute to the advancement of scientific knowledge on COVID-19.

You may personally benefit from your participation in this project, but we cannot offer any guarantees.

To protect your identity, your information is linked to a code and not to your name. The key to the code that links your name to your research file is kept by the study investigator.

Decoding can only be performed by the investigator or a representative.

You have the right to ask for the removal of your information at any time.

Yes. We recognize that the sampling in the PROVID-LD study may cause some inconvenience and loss of time. Participants will receive financial compensation. This compensation is however conditional on the completion of all steps involved in the study. All details will be communicated during the first phone call with our team.