CompletedPhase 1

Efficacy of UMT in CG Patients With PL

China110 participantsStarted 2025-02-01

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Symptom Response Assessed by ≥50% Reduction in Interstitial Cystitis Symptom Index (ICSI) Score

Timeframe: Week 12 (12 weeks after the first intravesical instillation)

Trial details

NCT IDNCT07530627

SponsorPeking University First Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-30

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