Status:
COMPLETED
Fecal Microbiota Translantation (FMT) to Reduce Inflammation in PLWH: The Gutsy Pilot Study
Lead Sponsor:
Jean-Pierre Routy
Collaborating Sponsors:
St. Joseph's Health Care London
Conditions:
HIV-1-infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this randomized, single blind, two-armed pilot study is to assess the efficacy of FMT in reducing gut mucosal and systemic inflammation in ART-treated people living with HIV with low CD4/C...
Detailed Description
Background: HIV infection is characterized by a rapid mucosal CD4 T-cell depletion and early epithelial gut damage. People living with HIV (PLWH) have an abnormal gastrointestinal landscape characteri...
Eligibility Criteria
Inclusion
- Male or female adults ≥18 years of age.
- Documented HIV-1 infection by Western Blot, Enzyme Immuno Assay (EIA) or viral load assay.
- On ART for at least 3 years, and stable ART regimen (same prescription) for at least 3 months.
- Undetectable viral load \< 50 copies/ml for the past 3 years. Viral blips below 200 copies/ml, are allowed if preceded and followed by a HIV viremia below 50 copies/ml.
- CD4 count between greater than 200 cells/µL and a CD4/CD8 ratio below 1 to select people with higher risks of inflammatory non-AIDS comorbidities and dysbiosis.
- Able to communicate adequately in either French or English.
- Able and willing to provide written informed consent prior to screening.
- Women of childbearing potential must have a negative serum pregnancy test at Screening
- Women of childbearing potential must agree to use one of the following approved methods of birth control while in the study and until 2 weeks after completion of the study (See Section 7.1):
- Complete abstinence from penile-vaginal intercourse from the screening period until 2 weeks after study completion.
- Double barrier method (acceptable barrier methods include diaphragm, coil, contraceptive foam, sponge with spermicide, or condom).
- Oral, injectable or implant contraceptives plus one barrier method.
- Any intrauterine device (IUD) with published data showing that the expected failure rate is \<1% per year (not all IUDs meet this criterion) plus one barrier method.
- Male partner sterilization confirmed prior to the female participant's entry into the study; this male is the sole partner for that participant.
- Approved hormonal contraception, started at least 30 days before screening, preferably with one barrier method.
- Another method approved by the Investigator with published data showing that the expected failure rate is \<1% per year preferably with one barrier method.
- Women of non-child-bearing potential as defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy.
- Sexually active men with a female partner of childbearing potential must agree to one of the following methods of birth control (See Section 7.1):
- The use of at least one barrier method of contraception (e.g. condom) with a female partner using a second approved method of contraception (IUD, hormonal contraceptive pill, diaphragm, spermicide, etc.) during the study and until two weeks after study completion.
- Have had a successful vasectomy.
- Be confirmed sterile. Any contraception method must be used consistently, in accordance with this study protocol, and for the duration of the study until two weeks after study completion.
Exclusion
- Known allergy/hypersensitivity Polyethylene glycol.
- Current AIDS-related event or serious health condition including systemic infections in the last 3 months.
- Severe systemic diseases (e.g. uncontrolled hypertension, chronic renal failure), or active uncontrolled infections.
- Co-infection with active Hepatitis B or C Virus.
- Current use or have used in the past 3 months: immune-modulatory agents, prophylactic antibiotics45/antibiotics, or Morphine as these drugs modulate gut microbiota.
- Diagnosis of diabetes mellitus (HbA1c≥6.5%) as defined by the Canadian Clinical Practice Guidelines for the Prevention and Management of Diabetes46.
- Recent changes in dietary habits, intermittent fasting, chronic constipation or laxative use as these can affect gut microbiota.
- Psychiatric or cognitive disturbance or any illness that could preclude compliance with the study.
- Current participation in an experimental therapy study or receipt of experimental therapy within the last 6 months.
- Women who are planning to become or who are pregnant, or breast-feeding.
- A score of higher than 8 on a Full AUDIT questionnaire at the screening visit, suggesting an alcohol abuse problem.
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06022406
Start Date
July 31 2024
End Date
August 13 2025
Last Update
September 3 2025
Active Locations (1)
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1
Chronic Viral Illness Service
Montreal, Quebec, Canada, H4A 3J1