Antiretroviral therapy (ART) controls HIV infection and helps improve the health and quality of life of people living with HIV. However, even when antiretroviral treatment is followed correctly, inflammation persists. This inflammation can increase the risk of cardiovascular disease, brain dysfunction and sometimes cancer. To reduce this inflammation, it is necessary to develop anti-inflammatory therapies. Dr. Jean-Pierre Routy’s team at the McGill University Health Center (MUHC) in Montreal is evaluating the effectiveness of fecal transplantation (the Gutsy study) and participants are being sought. If you are living with HIV, you will be told how you can join the study.
The Gutsy study is a study aimed at improving the health of people living with HIV (PLHIV) on antiretroviral treatment (ART).
Despite the remarkable success of ART in blocking the virus from multiplying and making it undetectable, inflammation persists in PLHIV and can increase the risk of health problems. Inflammation comes in particular from the intestine where the microbiota (the microbes that normally live in our intestine) of PLHIV lack beneficial bacteria. This microbiota is complex and contains tens of billions of microorganisms, including at least 1000 different types of bacteria. Many bacteria are “good” and act as a barrier to prevent intestinal damage and inflammation. ART alone is not enough to improve the composition of the microbiota. We are therefore seeking to rebalance the microbiota of PLHIV, to reduce inflammation. For this, our study explores an innovative solution: fecal microbiota transplantation (FMT).
What is fecal microbiota transplantation?
FMT involves replacing a recipient’s gut microbes with those of a healthy donor, thereby introducing beneficial gut bacteria from the gut. To do this, we put the donor’s microbiota in special capsules which will dissolve in the intestine and not in the stomach (see photo).
This method has shown promising results in improving gut health and reducing inflammation in other diseases such as C difficile infections, chronic bowel diseases or certain cancers.
The goal of the Gutsy study is to see if FMT capsules taken with antiretroviral drugs can reduce inflammation. For PLHIV, Health Canada authorizes the use of FMT in the Gutsy study to evaluate the modification of the intestinal microbiota to reduce inflammation. It may also improve immune function, and reduce the risk of inflammation.
Why participate?
By joining this study, you will be able to:
• Contribute to research that could improve treatments and the quality of life of PLHIV.
• Help understand the influence of gut health on people’s overall well-being.
Who can participate?
We are looking for participants:
• Living with HIV on ART with an undetectable viral load for at least three years.
• Aged 18 or over.
• Presenting specific immune markers (such as a low CD4/CD8 ratio).
• Not having an active co-infection with the hepatitis B or C virus.
• Not taking an antibiotic for 3 months
What to expect?
The Gutsy study is a study with a control group (placebo). During 6 visits to the MUHC clinic, the team will examine the participant’s medical history. Blood tests will be taken to ensure that the virus remains undetectable and also to measure the level of inflammation. At each visit, we will ask participants to collect a stool sample at home. Participants will take 30 to 40 capsules of TMF or capsules with a neutral product at two visits, then will be followed for 3 months.
Follow-up visits will be arranged to assess changes in gut health and immune function. All procedures are safe, and everyone’s privacy is our priority. Participation is voluntary and participants can withdraw from the study whenever they wish. Financial compensation will be offered for each visit.
Join our study to advance science and improve the lives of PLHIV.
For more information, contact our team: Carolina Berini, Research Coordinator: [email protected] or 514 934 1934 ext 34240 or Josée Girouard, research nurse: [email protected]
The Gutsy study (CTN PT038) is authorized by Health Canada and the MUHC Ethics Committee (#MP-37-2022-8695), and is a study supported by the CTN (CTN PT038, https://www. ctnplus.ca/en/study/ctnpt-038-letude-gutsy/.) clinicaltrials.gov number: NCT06022406
