Bladder bacteria transplant shows promise for painful condition
NCT ID NCT07530627
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 1 trial tested a new treatment called urinary microbiota transplantation (UMT) for people with cystitis glandularis, a chronic bladder condition often linked to pelvic lipomatosis. The treatment involves placing processed donor urine bacteria into the bladder. After one month of weekly treatments, the UMT group reported fewer symptoms like frequent urination and pain, with a 58% response rate. The study suggests UMT works by reducing harmful metabolites and inflammation, not by killing bacteria.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Urinary microbiota transplantation (UMT)
- What this could lead to
- If successful, this could offer a new treatment option for people with cystitis glandularis who have not responded to standard therapies.
- What could go wrong
- This is an early phase 1 trial with a small number of participants. The long-term safety and effectiveness are not yet known, and the treatment may not work for everyone.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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110 people
The number who actually took part.
- Started
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Feb 2025
- Finished
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Feb 2026
- Lead sponsor
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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 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * Age ≥ 18 years at the time of screening * Histologically confirmed high-risk chronic cystitis (pathological grade ≥ 3 or presence of dysplasia) * Elevated urinary ceramide (Cer(d18:1/18:0)) level ≥ 50 ng/mL at baseline * History of failure with standard-of-care therapy for chronic cystitis * Ability to provide written informed consent and comply with study procedures and follow-up * Ability to complete patient-reported outcome questionnaires (e.g., ICSI) independently Exclusion Criteria: * Active urinary tract infection (UTI) or untreated genitourinary tract infection at screening * Severe systemic diseases (e.g., uncontrolled diabetes, malignant tumor, severe cardiovascular/hepatic/renal dysfunction) that may interfere with study evaluation * History of bladder cancer, intravesical chemotherapy or immunotherapy within the past 6 months * Pregnancy or breastfeeding, or planned pregnancy during the study period * Participation in another interventional clinical trial within the past 3 months * Known allergy or hypersensitivity to any component of the UMT product or placebo (normal saline) * Severe mental illness or cognitive impairment that prevents completion of study assessments * Any other condition that, in the investigator's judgment, makes the participant unsuitable for 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
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Peking University First Hospital
Beijing, Beijing Municipality, 100034, China