Poop pills could tame HIV inflammation
NCT ID NCT06022406
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested whether taking capsules containing healthy donor stool (fecal microbiota transplantation, or FMT) can reduce gut inflammation in people with HIV who are on antiretroviral therapy (ART) but have a low CD4/CD8 ratio. Twenty participants were randomly assigned to receive either FMT or placebo capsules twice, three weeks apart. Researchers measured changes in gut permeability and inflammation markers in the blood and, in a substudy, in colon biopsies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fecal microbiota transplantation (FMT) capsules
- What this could lead to
- If it works, this could point toward a way to reduce chronic inflammation in people with HIV, potentially lowering the risk of long-term health problems.
- What could go wrong
- This is a very small, early pilot study with only 20 participants. The treatment may not reduce inflammation, and the effects may not be lasting or generalizable to all people with HIV.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
20 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Aug 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female adults ≥18 years of age. 2. Documented HIV-1 infection by Western Blot, Enzyme Immuno Assay (EIA) or viral load assay. 3. On ART for at least 3 years, and stable ART regimen (same prescription) for at least 3 months. 4. 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. 5. 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. 6. Able to communicate adequately in either French or English. 7. Able and willing to provide written informed consent prior to screening. 8. Women of childbearing potential must have a negative serum pregnancy test at Screening 9. 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): 1. Complete abstinence from penile-vaginal intercourse from the screening period until 2 weeks after study completion. 2. Double barrier method (acceptable barrier methods include diaphragm, coil, contraceptive foam, sponge with spermicide, or condom). 3. Oral, injectable or implant contraceptives plus one barrier method. 4. 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. 5. Male partner sterilization confirmed prior to the female participant's entry into the study; this male is the sole partner for that participant. 6. Approved hormonal contraception, started at least 30 days before screening, preferably with one barrier method. 7. Another method approved by the Investigator with published data showing that the expected failure rate is \<1% per year preferably with one barrier method. 10. 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. 11. 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): 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. 2. Have had a successful vasectomy. 3. 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 Criteria: 1. Known allergy/hypersensitivity Polyethylene glycol. 2. Current AIDS-related event or serious health condition including systemic infections in the last 3 months. 3. Severe systemic diseases (e.g. uncontrolled hypertension, chronic renal failure), or active uncontrolled infections. 4. Co-infection with active Hepatitis B or C Virus. 5. Current use or have used in the past 3 months: immune-modulatory agents, prophylactic antibiotics45/antibiotics, or Morphine as these drugs modulate gut microbiota. 6. Diagnosis of diabetes mellitus (HbA1c≥6.5%) as defined by the Canadian Clinical Practice Guidelines for the Prevention and Management of Diabetes46. 7. Recent changes in dietary habits, intermittent fasting, chronic constipation or laxative use as these can affect gut microbiota. 8. Psychiatric or cognitive disturbance or any illness that could preclude compliance with the study. 9. Current participation in an experimental therapy study or receipt of experimental therapy within the last 6 months. 10. Women who are planning to become or who are pregnant, or breast-feeding. 11. A score of higher than 8 on a Full AUDIT questionnaire at the screening visit, suggesting an alcohol abuse problem.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chronic Viral Illness Service
Montreal, Quebec, H4A 3J1, Canada
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