Active not recruitingOBSERVATIONAL

The MISTRAL Study: Gut Microbiome Correlates of Serious AIDS and Non-AIDS Events

The MISTRAL study is exploring the link between the bacteria in our gut (the 'gut microbiome') and HIV. Specifically, it's looking at how these tiny organisms might influence serious health issues, including inflammation and AIDS-related complications, in people living with HIV, especially those aged 50 or older. This important European project, running until 2025, hopes to discover 'biomarkers' in the gut that could help develop new ways to prevent HIV infection, improve existing treatments, and boost the effectiveness of vaccines. Ultimately, its goal is to use this knowledge to benefit millions worldwide affected by or at risk of HIV, making gut microbiome science more relevant to everyday medical care.

At a glance

Status

Active not recruiting

Sponsor

Rigshospitalet, Denmark

Enrolment target

991

Start

28 Sep 2022

Estimated completion

01 Dec 2025

HIV-1-infection Inflammation AIDS

What is this study about?

The MISTRAL study is an important European research project looking into how the 'gut microbiome' – that's all the bacteria and other tiny organisms living in our digestive system – affects people living with HIV. We know that these gut bugs play a big role in our overall health, and scientists are increasingly finding connections between them and various diseases.

For people with HIV, understanding the gut microbiome could be crucial. This study aims to find out if specific patterns in gut bacteria can predict who might be at higher risk of complications like chronic inflammation (long-lasting swelling in the body), or if these patterns influence how well someone responds to HIV treatments and vaccines. The hope is that by identifying these links, researchers can develop new strategies to improve health outcomes, reduce long-term problems, and make medicines and vaccines more effective for people with HIV. The MISTRAL team is made up of leading experts in HIV and gut health, working together to unlock these secrets and bring microbiome science closer to helping patients.

This research is particularly significant because HIV remains a major global health challenge, with new infections still rising in some parts of the world. While existing treatments are very good, there are still many unanswered questions about how to further improve the lives of people with HIV and potentially prevent new infections. The MISTRAL study is contributing to this effort by using samples from a well-established group of people living with HIV across Europe, building on years of existing research.

Key takeaways

The study explores links between gut bacteria and HIV health.
Aims to improve care for people living with HIV through new discoveries.
Uses existing data and samples from the EuroSIDA patient group.
Focuses on people with HIV aged 50 and over.
Could lead to better HIV prevention, treatments, and vaccines.
No new interventions or visits for participants.

Who may be eligible?

To be considered for the MISTRAL study, participants must be living with HIV and be at least 50 years old. They must also already be part of a long-standing patient group called EuroSIDA, which has been regularly collecting health information from people with HIV since 1994. This helps the researchers use existing, detailed health records.

There are also some reasons why someone might not be able to join the study. For instance, if they have severe kidney or advanced liver disease, or another serious illness that is currently life-threatening, they wouldn't be eligible. The study also excludes those who have recently experienced serious health issues like a heart attack or stroke, certain types of severe AIDS-related infections within the last five years, or specific AIDS or non-AIDS cancers (though common non-melanoma skin cancers are usually acceptable). These exclusions help ensure the study focuses on a specific group and that participants are well enough to take part without additional health risks.

Quick self-check

Are you living with HIV?
Are you 50 years old or older?
Are you already a participant in the EuroSIDA study?
Do you have severe kidney disease or advanced liver disease (Child-Pugh C)? (If yes to these, you may not be eligible.)
Have you recently experienced a heart attack, stroke, or severe AIDS-related infection within the last 5 years? (If yes, you may not be eligible.)

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

The MISTRAL study doesn't involve any new treatments or extra clinic visits. Instead, it uses information and samples, like stool, plasma (the liquid part of blood), and blood, that have already been collected from participants as part of their routine care within the EuroSIDA study. If you're eligible and already in the EuroSIDA group, your participation would involve the research team analysing these existing samples and health data. There are no additional assessments or follow-up appointments specifically for MISTRAL, as it utilises the ongoing collection of data from EuroSIDA. The total duration of your 'involvement' would be the period over which your existing data and samples are analysed as part of this project, which runs until the end of 2025.

Potential risks and benefits

Participating in the MISTRAL study directly carries very low risk, as it primarily involves the analysis of existing, anonymised samples and data already collected during routine care for the EuroSIDA study. There are no new procedures or medications. The main benefit is contributing to vital scientific knowledge that could lead to improved understanding, prevention, and treatment of HIV, potentially benefiting millions globally. Because no direct interventions are being tested, individual benefits are not guaranteed. As with any medical study, you always have the right to withdraw your consent for your data and samples to be used in future research, even if they have already been collected.

Locations (22)

CHU Saint-Pierre Hospital
Brussels, Belgium
University Hospital of Infectious Diseases
Zagreb, Croatia
Faculty Hospital Bulovka
Prague, Czechia
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Hvidovre Universitets Hospital
Hvidovre, Denmark
Odense Universitetshospital
Odense, Denmark
University Hospital Bonn, Klinisches StudieZentrum Immun.
Bonn, Germany
University Hospital Cologne
Cologne, Germany
University Clinic Hamburg Eppendorf
Eppendorf, Germany
J.W.Goethe University Hospital
Frankfurt am Main, Germany
ICH Study Center, Innere Medizin
Hamburg, Germany

+10 more sites — see the official record for the full list.

Common questions

What is the 'gut microbiome'?

It's all the tiny bacteria and other organisms that live in your digestive system, playing an important role in your health.

Who is funding this research?

The MISTRAL study is funded by the European Union's Horizon 2020 project, which supports innovative research.

Do I need to take any new medication if I participate?

No, this study does not involve any new medications, treatments, or extra clinic visits for participants.

Will my personal information be kept private?

Yes, all data and samples used in research studies are handled very carefully to protect your privacy and are often made anonymous.

How long will the MISTRAL study last?

The MISTRAL project officially started in 2020 and is planned to run until the end of 2025.