CTNPT 022A: PROOV IT I

About The Study

The purpose of this pilot study was to determine if taking a probiotic at the beginning of antiretroviral therapy (ART) can more quickly reduce inflammation and harmful immune activation compared to taking ART alone.

Probiotic products are live bacteria that may provide health benefits and are often referred to as “beneficial” bacteria. The specific probiotic used in this study, Visbiome, was approved by Health Canada as a Natural Health Product. However, its use in this research study is experimental.

About The Disease

Consistent use of ART to manage HIV is known to extend life expectancy by many years. However, many people living with HIV have more inflammation and immune activation–related health conditions (like heart and brain diseases) compared to uninfected people, even after taking ART for a long period of time. This may be a result of bacteria entering the bloodstream through a person’s gut lining that has been damaged by HIV. Although ART has drastically improved HIV care, it can take many years of continuous ART to repair HIV-related damage to the immune cells in the gut.

This study investigated whether it is possible to fix the damage to gut tissue faster by taking probiotics along with ART. Fixing the gut tissue more quickly may have benefits, since the longer a person experiences this damage the more likely it is that they may experience negative health outcomes.

There is considerable evidence that a change in the balance of beneficial and harmful bacteria influences gut immune health. For example, beneficial bacteria have been shown to enhance the ability of immune cells to fight harmful bacteria. Therefore, we think that probiotics may improve the function and number of healthy immune cells in the gut to prevent the leakage into the bloodstream and ultimately reduce HIV-related health complications.

Study Approach

The planned duration of the study was 24 weeks with the option of extending it to up to 48 weeks. During the blinded portion of the study (in the first 24 weeks), participants would be randomly placed into one of two groups. The first part of the study was double-blinded meaning that neither the participants or their doctor will know which treatment group they were in.

1. Probiotic treatment group: Probiotic Visbiome (two sachets daily) + standard ART
2. Control treatment group: Placebo (two sachets daily) + standard ART. A placebo has no active ingredient but looks the same as Visbiome.

Participants would take the sachets as they start ART for 24 weeks without knowing which study group they are in. At the 24-week study visit, participants would be offered to further participate in the study and take Visbiome for an additional 24 weeks. This second portion of the study was open-label, meaning participants will know that they were taking Visbiome. Bloodwork and questionnaire material were collected periodically throughout the course of the study. This information would be used to assess immune function, inflammation, and gut health between the two study groups.

Results

This study was terminated early due to futility analysis.