Poop pills could supercharge cancer immunotherapy
NCT ID NCT04758507
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested whether transplanting gut bacteria from people who responded well to immunotherapy could help others with advanced kidney cancer respond better. Fifty participants received either a fecal transplant or a placebo. The goal was to see if the transplant could slow tumor growth and improve treatment outcomes.
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 transplant (FMT) from donors responding to immunotherapy
- What this could lead to
- If it works, this could offer a way to boost the effectiveness of immunotherapy for advanced kidney cancer by changing the gut bacteria.
- What could go wrong
- This is an early-phase trial with only 50 participants, so results may not apply to everyone. FMT carries risks of infection or side effects, and the benefit is unproven.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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50 people
The number who actually took part.
- Started
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Feb 2021
- Finished
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Jul 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
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18 to 80 years
- Sex
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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: * Histologically confirmed aRCC * Metastatic disease (measurable and not-measurable) * Radiological assessment within 8 wks before enrollment * Patient eligible to therapy with ICI for aRCC (or started within 8 wks) * Ability to provide written informed consent * Ability to be compliant with the scheduled procedures Exclusion Criteria: * Major comorbidities * Concomitant GI or autoimmune disorders, or HIV, HBV, HCV infection * Continuative corticosteroid therapy * Previous treatment with systemic immune-suppressants or immune-modulatory drugs * Antibiotic therapy within 4 weeks prior to enrollment
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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
-
Digestive Disease Center
Rome, Rome, 00168, Italy
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Gianluca Ianiro
Rome, Rome, 00168, Italy
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Other studies related to the condition(s) this trial covers.
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