HIV-1-infectionPhase 2GutsyNCT06022406
Fecal Microbiota Translantation (FMT) to Reduce Inflammation in PLWH: The Gutsy Pilot Study
A Phase 2 study testing FMT capsules in people with HIV-1-infection, run by Jean-Pierre Routy at 1 site in Canada.
Trial 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/CD8 ratio. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- FMT capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jul 2024to 13 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fecal Microbiota Transplantation to Reduce Immune Activation in ART-treated People Living With HIV With Low CD4/CD8 Ratio: The Gutsy Study
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/CD8 ratio. The main questions it aims to answer are: •Is there a change in the gut permeability among participants taking FMT compared to placebo? • Has inflammation been reduced by the use of FMT? Ten participants will be randomized to receive FMT in capsules, and another 10 participants will receive placebo capsules containing microcrystalline cellulose. Capsules will be given twice (30 to 40 capsules at each treatment) at 3 weeks interval, to ensure engraftment. In an optional substudy, participants will be asked to undergo colonoscopy before and 3 months after FMT to assess gut inflammation and HIV reservoir size in colon biopsies. Researchers will compare the FMT arm and the Placebo arm to see if there are differences in gut permeability and inflammation.
Read the 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 characterized by villous atrophy, crypt hyperplasia, loosened tight junctions, gastrointestinal inflammation and increased intestinal permeability. Despite long-term antiretroviral therapy (ART), gut mucosa damage remains in PLWH. Increased gut permeability allows the translocation of microbial products into the mucosa and the blood. This process, called microbial translocation, has been associated with increased inflammation and the development of non-AIDS events such as cardiovascular diseases, neurocognitive dysfunction and some cancers in ART-treated PLWH.
Gut damage and persistent inflammation were associated with the modification of the gut microbiota, called dysbiosis, which persists in PLWH under ART. Hence, therapies targeting the gut mucosa are a must.
Minor changes were obtained with Lactobacillus-based probiotics aiming at balancing microbiota composition in PLWH. A promising intervention is the use of fecal microbial transplantation (FMT), which consist of delivering stool microbiota from a donor by upper-endoscopy in the stomach or colonoscopy. More recently, oral delivery of encapsulated stool preparation was shown to lead to a more stable engraftment of the donor's microbiota. FMT was primarily used to eliminate Clostridium difficile infection. FMT is not commonly used in PLWH, but macaque models gave promising results with reduced gut inflammation post FMT in SIV-infected monkeys.
Objectives: To assess, before and after FMT, in the FMT compared to place group:
- Plasma levels of gut damage markers (Intestinal Fatty acid Binding protein) and the new marker of gut permeability Regenerating Islet Derived protein 3 α (REG3α).
- Inflammatory cytokines and T and Myeloid cell activation in blood and colon biopsies
- Changes in stools microbiota composition
- Changes in mucosal and blood HIV reservoir size
- Safety of FMT
Methods: To perform a randomized, single blind, two-armed pilot study in HIV-infected ART treated participant with a low CD4/CD8 ratio which are at higher risk of inflammation and dysbiosis. Ten participants will be randomized to receive FMT in capsules, and another 10 will receive placebo capsules containing microcrystalline cellulose. Capsules will be given twice (30 to 40 capsules at each treatment) at 3 weeks interval, to ensure engraftment. Safety will be assessed. In an optional substudy, participants will be asked to undergo colonoscopy before and 3 months after FMT to assess gut inflammation and HIV reservoir size in colon biopsies.
Anticipated results: We expect that FMT will reduce gut mucosal and systemic inflammation. This study should provide sufficient results for calculation of power in a larger scale trial in PLWH.
- Conditions
- HIV-1-infection
- Being tested
- FMT capsules, Placebo capsules
- Keywords
- HIV, Low CD4/CD8 ratio, Dysbiosis
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT capsulesBiological
Formulation: 80-100g of healthy donor stool processed, frozen and encapsulated in gelatin capsules (modified Kao et al, 2017).
Placebo capsulesBiological
Formulation: microcrystalline cellulose, for equivalence in weight and color, will be encapsulated in gelatin capsules. Each capsule will be filled with approximatively 5.5g of microcrystalline cellulose, and encapsulated in size 0 and size 00 capsules.
| Study group | Role | What they receive |
|---|---|---|
| FMT capsules | Experimental | 10 participants taking FMT. The study product consists of fecal microbiota capsules prepared by Dr. Silverman's team in London, Ontario, Canada. Dr. Silverman has received approval from Health Canada to evaluate FMT in patients with metastatic malignant melanoma or with fatty liver within a clinical trial setting (CTA control nos. 235387and 195078 respectively).
Approximately 30 to 40 capsules will be prepared from 80-100g of healthy human feces from a single healthy donor and administered as a single dose. Capsules will be prepared by a modified method as described by Kao et al, 201747,48 (see Investigator brochure). Receives: Biological: FMT capsules |
| Placebo capsules | Placebo comparator | 10 participants taking Placebo. Placebo capsules contain microcrystalline cellulose, for equivalence in weight and color that will be encapsulated in gelatin capsules. Each capsule will be filled with approximatively 5.5g of microcrystalline cellulose, and encapsulated in size 0 and size 00 capsules. Receives: Biological: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
REG3α levels
Changes in plasma REG3α levels will be measured as markers of gut permeability
Measured: 12 weeks
Secondary outcomes (17)
Safety of FMT
Safety of FMT measured by evaluating adverse events.
Measured: 12 weeks
Tolerability of FMT
tolerability of FMT measured by evaluating adverse events.
Measured: 12 weeks
Changes in plasma levels of gut damage markers
Changes in plasma levels of gut damage markers (I-FABP)
Measured: 12 weeks
Changes in plasma levels of gut damage markers
Changes in plasma levels of gut damage markers (LPS).
Measured: 12 weeks
Changes in Plasma levels of pro-inflammatory markers
Changes in Plasma levels of (1-3)-β-D-Glucan will be measured by Multiplex or ELISA.
Measured: 12 weeks
Changes in Plasma levels of pro-inflammatory markers
Changes in Plasma levels of IL-1β will be measured by Multiplex or ELISA.
Measured: 12 weeks
Changes in Plasma levels of pro-inflammatory markers
Changes in Plasma levels of IL-6 will be measured by Multiplex or ELISA.
Measured: 12 weeks
Changes in Plasma levels of pro-inflammatory markers
Changes in Plasma levels of IL-8 will be measured by Multiplex or ELISA.
Measured: 12 weeks
Changes in Plasma levels of pro-inflammatory markers
-Changes in Plasma levels of IP-10 will be measured by Multiplex or ELISA.
Measured: 12 weeks
Changes in Plasma levels of pro-inflammatory markers
Changes in Plasma levels of IL-17A and F will be measured by Multiplex or ELISA.
Measured: 12 weeks
Changes in Plasma levels of pro-inflammatory markers
Changes in Plasma levels of IL-22 will be measured by Multiplex or ELISA.
Measured: 12 weeks
Changes in Plasma levels of anti-inflammatory markers
Changes in Plasma levels of IL-10 will be measured by Multiplex or ELISA.
Measured: 12 weeks
Changes in Plasma levels of anti-inflammatory markers
Changes in Plasma levels of IL-37 will be measured by Multiplex or ELISA.
Measured: 12 weeks
Changes in T cell activation in blood
Changes in T cell activation in blood, as assessed by flow cytometry expression of HLA-DR
Measured: 12 weeks
Changes in T activation in blood
Changes in T cell activation in blood, as assessed by flow cytometry expression of CD38
Measured: 12 weeks
Changes in myeloid cell activation in blood
Changes in myeloid cell activation in blood, as assessed by flow cytometry expression of CD83
Measured: 12 weeks
Changes in myeloid cell activation in blood
Changes in myeloid cell activation in blood, as assessed by flow cytometry expression of CD86
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start31 Jul 2024
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, randomized, placebo-controlled, interventional study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean-Pierre Routy
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Health Care London
- Responsible party
- Sponsor-investigator, Jean-Pierre Routy, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Carolina Berini, Dr., Study director, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022406
- Sponsor's protocol ID
- 2023-9477
- Acronym
- Gutsy
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Isnard S, Berini CA, Parvathy SN, Feng H, Aiyana O, Royston L, Mabanga T, Lakatos PL, Bessissow T, Klein MB, Lebouche B, Costiniuk CT, Routy B, Silverman MS, Routy JP. Fecal microbiota transplantation to reduce immune activation in ART-treated people with HIV with low CD4/CD8 ratio: protocol for the single-blind, randomized, placebo-controlled Gutsy study (CIHR/CTN PT038). Trials. 2025 Dec 13;27(1):52. doi: 10.1186/s13063-025-09345-0.
PubMed 41390455
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation to Reduce Immune Activation in ART-treated People Living With HIV With Low CD4/CD8 Ratio: The Gutsy Study
- ClinicalTrials.gov ID
- NCT06022406
- Acronym / sponsor ID
- Gutsy / 2023-9477
- Conditions
- HIV-1-infection
- Keywords
- HIV, Low CD4/CD8 ratio, Dysbiosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jean-Pierre RoutyUniversity, hospital or other
- Collaborators
- St. Joseph's Health Care London
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/CD8 ratio. The main questions it aims to answer are: •Is there a change in the gut permeability among participants taking FMT compared to placebo? • Has inflammation been reduced by the use of FMT? Ten participants will be randomized to receive FMT in capsules, and another 10 participants will receive placebo capsules containing microcrystalline cellulose. Capsules will be given twice (30 to 40 capsules at each treatment) at 3 weeks interval, to ensure engraftment. In an optional substudy, participants will be asked to undergo colonoscopy before and 3 months after FMT to assess gut inflammation and HIV reservoir size in colon biopsies. Researchers will compare the FMT arm and the Placebo arm to see if there are differences in gut permeability and inflammation.
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 characterized by villous atrophy, crypt hyperplasia, loosened tight junctions, gastrointestinal inflammation and increased intestinal permeability. Despite long-term antiretroviral therapy (ART), gut mucosa damage remains in PLWH. Increased gut permeability allows the translocation of microbial products into the mucosa and the blood. This process, called microbial translocation, has been associated with increased inflammation and the development of non-AIDS events such as cardiovascular diseases, neurocognitive dysfunction and some cancers in ART-treated PLWH.
Gut damage and persistent inflammation were associated with the modification of the gut microbiota, called dysbiosis, which persists in PLWH under ART. Hence, therapies targeting the gut mucosa are a must.
Minor changes were obtained with Lactobacillus-based probiotics aiming at balancing microbiota composition in PLWH. A promising intervention is the use of fecal microbial transplantation (FMT), which consist of delivering stool microbiota from a donor by upper-endoscopy in the stomach or colonoscopy. More recently, oral delivery of encapsulated stool preparation was shown to lead to a more stable engraftment of the donor's microbiota. FMT was primarily used to eliminate Clostridium difficile infection. FMT is not commonly used in PLWH, but macaque models gave promising results with reduced gut inflammation post FMT in SIV-infected monkeys.
Objectives: To assess, before and after FMT, in the FMT compared to place group:
- Plasma levels of gut damage markers (Intestinal Fatty acid Binding protein) and the new marker of gut permeability Regenerating Islet Derived protein 3 α (REG3α).
- Inflammatory cytokines and T and Myeloid cell activation in blood and colon biopsies
- Changes in stools microbiota composition
- Changes in mucosal and blood HIV reservoir size
- Safety of FMT
Methods: To perform a randomized, single blind, two-armed pilot study in HIV-infected ART treated participant with a low CD4/CD8 ratio which are at higher risk of inflammation and dysbiosis. Ten participants will be randomized to receive FMT in capsules, and another 10 will receive placebo capsules containing microcrystalline cellulose. Capsules will be given twice (30 to 40 capsules at each treatment) at 3 weeks interval, to ensure engraftment. Safety will be assessed. In an optional substudy, participants will be asked to undergo colonoscopy before and 3 months after FMT to assess gut inflammation and HIV reservoir size in colon biopsies.
Anticipated results: We expect that FMT will reduce gut mucosal and systemic inflammation. This study should provide sufficient results for calculation of power in a larger scale trial in PLWH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind, randomized, placebo-controlled, interventional study
| Arm | Type | Receives |
|---|---|---|
| FMT capsules | Experimental | Biological: FMT capsules10 participants taking FMT. The study product consists of fecal microbiota capsules prepared by Dr. Silverman's team in London, Ontario, Canada. Dr. Silverman has received approval from Health Canada to evaluate FMT in patients with metastatic malignant melanoma or with fatty liver within a clinical trial setting (CTA control nos. 235387and 195078 respectively). Approximately 30 to 40 capsules will be prepared from 80-100g of healthy human feces from a single healthy donor and administered as a single dose. Capsules will be prepared by a modified method as described by Kao et al, 201747,48 (see Investigator brochure). |
| Placebo capsules | Placebo comparator | Biological: Placebo capsules10 participants taking Placebo. Placebo capsules contain microcrystalline cellulose, for equivalence in weight and color that will be encapsulated in gelatin capsules. Each capsule will be filled with approximatively 5.5g of microcrystalline cellulose, and encapsulated in size 0 and size 00 capsules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMT capsulesFormulation: 80-100g of healthy donor stool processed, frozen and encapsulated in gelatin capsules (modified Kao et al, 2017). | Biological | FMT capsules |
| Placebo capsulesFormulation: microcrystalline cellulose, for equivalence in weight and color, will be encapsulated in gelatin capsules. Each capsule will be filled with approximatively 5.5g of microcrystalline cellulose, and encapsulated in size 0 and size 00 capsules. | Biological | Placebo capsules |
Primary outcome
REG3α levels
Time frame: 12 weeks
Changes in plasma REG3α levels will be measured as markers of gut permeability
17 secondary outcomes
Safety of FMT
Time frame: 12 weeks
Tolerability of FMT
Time frame: 12 weeks
Changes in plasma levels of gut damage markers
Time frame: 12 weeks
Changes in plasma levels of gut damage markers
Time frame: 12 weeks
Changes in Plasma levels of pro-inflammatory markers
Time frame: 12 weeks
Changes in Plasma levels of pro-inflammatory markers
Time frame: 12 weeks
Changes in Plasma levels of pro-inflammatory markers
Time frame: 12 weeks
Changes in Plasma levels of pro-inflammatory markers
Time frame: 12 weeks
Changes in Plasma levels of pro-inflammatory markers
Time frame: 12 weeks
Changes in Plasma levels of pro-inflammatory markers
Time frame: 12 weeks
Changes in Plasma levels of pro-inflammatory markers
Time frame: 12 weeks
Changes in Plasma levels of anti-inflammatory markers
Time frame: 12 weeks
Changes in Plasma levels of anti-inflammatory markers
Time frame: 12 weeks
Changes in T cell activation in blood
Time frame: 12 weeks
Changes in T activation in blood
Time frame: 12 weeks
Changes in myeloid cell activation in blood
Time frame: 12 weeks
Changes in myeloid cell activation in blood
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Derived from this study: PubMed 41390455Isnard S, Berini CA, Parvathy SN, Feng H, Aiyana O, Royston L, Mabanga T, Lakatos PL, Bessissow T, Klein MB, Lebouche B, Costiniuk CT, Routy B, Silverman MS, Routy JP. Fecal microbiota transplantation to reduce immune activation in ART-treated people with HIV with low CD4/CD8 ratio: protocol for the single-blind, randomized, placebo-controlled Gutsy study (CIHR/CTN PT038). Trials. 2025 Dec 13;27(1):52. doi: 10.1186/s13063-025-09345-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina Berini, Dr. study director
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FMT capsules in people with HIV-1-infection, run by Jean-Pierre Routy at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
REG3α levels (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06022406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.