Pelvic LipomatosisPhase 1NCT07530627
Efficacy of UMT in CG Patients With PL
A Phase 1 study testing Urinary Microbiota Transplantation (UMT) in people with Pelvic Lipomatosis and Cystitis Glandularis, run by Peking University First Hospital at 1 site in China.
Trial summary
To clinically validate the pathological role of Cer accumulation and evaluate a novel microbiota-targeted intervention, we conducted a comprehensive analysis of bladder mucosal specimens from a well-characterized patient cohort stratified according to the established histopathological criteria for CG severity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pelvic Lipomatosis, Cystitis Glandularis
- What is being tested?
- Urinary Microbiota Transplantation (UMT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 28 Feb 2026
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Efficacy of Urinary Microbiota Transplantation (UMT) in Cystitis Glandularis (CG) Patients With Pelvic Lipomatosis (PL)
To clinically validate the pathological role of Cer accumulation and evaluate a novel microbiota-targeted intervention, we conducted a comprehensive analysis of bladder mucosal specimens from a well-characterized patient cohort stratified according to the established histopathological criteria for CG severity. Our findings revealed specific accumulation of the sphingolipid species Cer(d18:1/18:0) in high-risk CG tissues, which was absent in both low-risk and control groups. Notably, tissue levels of Cer(d18:1/18:0) demonstrated a strong positive correlation with histopathological grade, highlighting its clinical relevance as a driver of PL-CG progression and supporting its potential utility as a prognostic biomarker.
Given the established association between the urinary microbiota and local metabolite production, and considering that the pathogenic urinary microbiota likely serves as the source of this immunomodulatory Cer, we designed and implemented a randomized controlled trial to assess therapeutic remodeling of the bladder microenvironment through UMT. Following the one-month regimen of weekly intravesical instillations, UMT significantly reduced disease burden in PL-CG patients. At the 12-week follow-up, the UMT group exhibited a substantially lower Interstitial Cystitis Symptom Index (ICSI) compared to controls, with an overall response rate of 58.18%. Significant improvements were also observed in key clinical symptoms, including daytime urinary frequency and voiding-related pain. Notably, clinical improvement occurred without a significant reduction in mucosal colonization levels of B. thetaiotaomicron. This observation suggests that UMT's efficacy does not arise from broad bacterial eradication but rather from functional modulation of the microbiota-host interface. Instead, therapeutic benefit was strongly associated with direct depletion of the pathogenic metabolite. Urinary Cer(d18:1/18:0) levels were markedly reduced following UMT, which coincided with the coordinated down-regulation of key pro-inflammatory cytokines in the bladder mucosa, including IL-6, TNF-α, IL-1β, and CXCL1. This sequential cascade thus establishes a clear mechanistic link between pathogenic metabolite clearance, resolution of inflammation, and symptomatic relief.
- Conditions
- Pelvic Lipomatosis, Cystitis Glandularis
- Being tested
- Urinary Microbiota Transplantation (UMT), 0.9% Sodium Chloride Injection (Normal Saline, Placebo)
- Medical subject headings
- Pelvic lipomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary Microbiota Transplantation (UMT)Biological
This intervention is a rigorously prepared donor-derived urinary microbiota transplantation product. After passing strict multi-pathogen screening, donor urine is processed via differential centrifugation (3000g for 10min, 10000g for 20min, 100000g for 60min) and sequential sterile filtration through 0.45μm and 0.22μm PES membranes to isolate and purify the microbial fraction. The microbial pellet is resuspended in sterile PBS (autoclaved at 121℃ for 20min), supplemented with 1μM myriocin and metabolite-rich supernatant, and confirmed sterile via final sterility testing before clinical use. Participants receive intravesical instillation once weekly for 4 consecutive weeks for the treatment of high-risk chronic cystitis/interstitial cystitis.
0.9% Sodium Chloride Injection (Normal Saline, Placebo)Drug
This arm receives intravesical instillation of sterile 0.9% sodium chloride injection (normal saline) as a placebo control. The placebo is identical in appearance, volume, and administration schedule to the urinary microbiota transplantation (UMT) product in the experimental arm, administered once weekly for 4 consecutive weeks to maintain the double-blind study design. The placebo has no therapeutic activity and is used to evaluate the efficacy and safety of UMT for the treatment of high-risk chronic cystitis/interstitial cystitis.
| Study group | Role | What they receive |
|---|---|---|
| UMT | Experimental | Participants in this arm will receive intravesical instillation of urinary microbiota transplantation (UMT) once weekly for 4 consecutive weeks. The UMT product is prepared from donor urine via differential centrifugation, sterile filtration, and reconstitution in sterile PBS, supplemented with myriocin and metabolite-rich supernatant, and confirmed sterile prior to administration. Receives: Biological: Urinary Microbiota Transplantation (UMT) |
| Control | Placebo comparator | Participants in this arm will receive intravesical instillation of sterile normal saline (placebo) once weekly for 4 consecutive weeks, following the same administration schedule and procedure as the experimental UMT arm. The placebo is identical in appearance and administration method to the UMT product to maintain the double-blind design. Receives: Drug: 0.9% Sodium Chloride Injection (Normal Saline, Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Response Assessed by ≥50% Reduction in Interstitial Cystitis Symptom Index (ICSI) Score
The primary efficacy endpoint is defined as a ≥50% reduction from baseline in the total Interstitial Cystitis Symptom Index (ICSI) score at Week 12 post-treatment initiation. The ICSI is a validated 4-item patient-reported outcome tool that quantifies the severity of interstitial cystitis/bladder pain syndrome symptoms, including urinary frequency, urgency, pain, and nocturia.
Measured: Week 12 (12 weeks after the first intravesical instillation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Feb 2025
- Primary completion30 Dec 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic LipomatosisStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530627
- Sponsor's protocol ID
- PKUFH-UMT-PL-CG-2025
- Status last verified
- Mar 2026
- First submitted
- 1 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Urinary Microbiota Transplantation (UMT) in Cystitis Glandularis (CG) Patients With Pelvic Lipomatosis (PL)
- ClinicalTrials.gov ID
- NCT07530627
- Acronym / sponsor ID
- PKUFH-UMT-PL-CG-2025
- Conditions
- Pelvic Lipomatosis, Cystitis Glandularis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 15 Apr 2026 (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.
To clinically validate the pathological role of Cer accumulation and evaluate a novel microbiota-targeted intervention, we conducted a comprehensive analysis of bladder mucosal specimens from a well-characterized patient cohort stratified according to the established histopathological criteria for CG severity. Our findings revealed specific accumulation of the sphingolipid species Cer(d18:1/18:0) in high-risk CG tissues, which was absent in both low-risk and control groups. Notably, tissue levels of Cer(d18:1/18:0) demonstrated a strong positive correlation with histopathological grade, highlighting its clinical relevance as a driver of PL-CG progression and supporting its potential utility as a prognostic biomarker.
Given the established association between the urinary microbiota and local metabolite production, and considering that the pathogenic urinary microbiota likely serves as the source of this immunomodulatory Cer, we designed and implemented a randomized controlled trial to assess therapeutic remodeling of the bladder microenvironment through UMT. Following the one-month regimen of weekly intravesical instillations, UMT significantly reduced disease burden in PL-CG patients. At the 12-week follow-up, the UMT group exhibited a substantially lower Interstitial Cystitis Symptom Index (ICSI) compared to controls, with an overall response rate of 58.18%. Significant improvements were also observed in key clinical symptoms, including daytime urinary frequency and voiding-related pain. Notably, clinical improvement occurred without a significant reduction in mucosal colonization levels of B. thetaiotaomicron. This observation suggests that UMT's efficacy does not arise from broad bacterial eradication but rather from functional modulation of the microbiota-host interface. Instead, therapeutic benefit was strongly associated with direct depletion of the pathogenic metabolite. Urinary Cer(d18:1/18:0) levels were markedly reduced following UMT, which coincided with the coordinated down-regulation of key pro-inflammatory cytokines in the bladder mucosa, including IL-6, TNF-α, IL-1β, and CXCL1. This sequential cascade thus establishes a clear mechanistic link between pathogenic metabolite clearance, resolution of inflammation, and symptomatic relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UMT | Experimental | Biological: Urinary Microbiota Transplantation (UMT)Participants in this arm will receive intravesical instillation of urinary microbiota transplantation (UMT) once weekly for 4 consecutive weeks. The UMT product is prepared from donor urine via differential centrifugation, sterile filtration, and reconstitution in sterile PBS, supplemented with myriocin and metabolite-rich supernatant, and confirmed sterile prior to administration. |
| Control | Placebo comparator | Drug: 0.9% Sodium Chloride Injection (Normal Saline, Placebo)Participants in this arm will receive intravesical instillation of sterile normal saline (placebo) once weekly for 4 consecutive weeks, following the same administration schedule and procedure as the experimental UMT arm. The placebo is identical in appearance and administration method to the UMT product to maintain the double-blind design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Urinary Microbiota Transplantation (UMT)This intervention is a rigorously prepared donor-derived urinary microbiota transplantation product. After passing strict multi-pathogen screening, donor urine is processed via differential centrifugation (3000g for 10min, 10000g for 20min, 100000g for 60min) and sequential sterile filtration through 0.45μm and 0.22μm PES membranes to isolate and purify the microbial fraction. The microbial pellet is resuspended in sterile PBS (autoclaved at 121℃ for 20min), supplemented with 1μM myriocin and metabolite-rich supernatant, and confirmed sterile via final sterility testing before clinical use. Participants receive intravesical instillation once weekly for 4 consecutive weeks for the treatment of high-risk chronic cystitis/interstitial cystitis. | Biological | UMT |
| 0.9% Sodium Chloride Injection (Normal Saline, Placebo)This arm receives intravesical instillation of sterile 0.9% sodium chloride injection (normal saline) as a placebo control. The placebo is identical in appearance, volume, and administration schedule to the urinary microbiota transplantation (UMT) product in the experimental arm, administered once weekly for 4 consecutive weeks to maintain the double-blind study design. The placebo has no therapeutic activity and is used to evaluate the efficacy and safety of UMT for the treatment of high-risk chronic cystitis/interstitial cystitis. | Drug | Control |
Primary outcome
Symptom Response Assessed by ≥50% Reduction in Interstitial Cystitis Symptom Index (ICSI) Score
Time frame: Week 12 (12 weeks after the first intravesical instillation)
The primary efficacy endpoint is defined as a ≥50% reduction from baseline in the total Interstitial Cystitis Symptom Index (ICSI) score at Week 12 post-treatment initiation. The ICSI is a validated 4-item patient-reported outcome tool that quantifies the severity of interstitial cystitis/bladder pain syndrome symptoms, including urinary frequency, urgency, pain, and nocturia.
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 15 Apr 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Urinary Microbiota Transplantation (UMT) in people with Pelvic Lipomatosis and Cystitis Glandularis, run by Peking University First Hospital at 1 site in China.
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 6 inclusion and 8 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 15 Apr 2026. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Symptom Response Assessed by ≥50% Reduction in Interstitial Cystitis Symptom Index (ICSI) Score (time frame: Week 12 (12 weeks after the first intravesical instillation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.