MISTRAL
Research type
Research Study
Full title
Gut microbiome correlates of serious AIDS and non-AIDS events
IRAS ID
306481
Contact name
Sarah L Pett
Contact email
Sponsor organisation
Rigshospitalet – University of Copenhagen CHIP, Section 2100
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 30 days
Research summary
All humans have trillions of micro-organisms (‘bugs’) in their gut, this is called ‘the microbiome’. In a healthy person, these “bugs” coexist peacefully with their human host, and a healthy microbiome is important for maintaining good health and longevity.
There is emerging evidence that a number of chronic medical conditions, including human immunodeficiency virus(HIV), are associated with an unhealthy microbiome. This unhealthy microbiome is linked to chronic inflammation, other medical conditions and premature aging.
The MISTRAL study is part of EuroSida, an observational study in people living with HIV (PLWH) running since 1994. MISTRAL aims to explore the make-up of the microbiome, how it changes over time, and how these changes might be linked to other medical problems, including AIDS (when the immune system is very damaged) and other serious conditions like heart disease, which is more common in PLWH than the general population.
MISTRAL is being conducted in EuroSida sites in the EU/UK. Participants are HIV-positive and ≥50 years. MISTRAL plans to enrol ≈455 PLWH in the UK. Participants who consent will be required to provide detailed clinical information about their diet, stool pattern, medications, and medical problems, have a blood sample taken, and provide a stool sample, and a second set of samples 10-24 months after the first. The stool samples will be used to describe their microbiome, and the blood samples analysed for markers of inflammation, to see how the two correlate. Clinical follow-up data will be collected annually for 2-4 years after enrolment.
It is known that the make-up of the microbiome, is influenced by the host’s own genetics. For this reason, MISTRAL participants will be invited, with a separate consent, for their study blood samples to undergo host genomic testing. This is optional, and a participant can join MISTRAL without consenting to genetic testing.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0023
Date of REC Opinion
21 Feb 2022
REC opinion
Further Information Favourable Opinion