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Bladder microbiota transplantation for the treatment of interstitial cystitis

Bladder microbiota transplantation for the treatment of interstitial cystitis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087947
Enrollment
Unknown
Registered
2024-08-07
Start date
2023-12-16
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial cystitis

Interventions

Experimental group:Bladder microbiota transplantation
Control group:Placebo

Sponsors

Wuxi No.2 People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Interstitial cystitis a)Age above 18 years old; b)Interstitial cystitis was diagnosed by clinical examination and diagnosis; c)Patients who failed to respond to conventional treatment or had recurrent attacks; d)Patients voluntarily participated in the treatment of bladder microbiota transplantation and signed the informed consent.; e)The patient had not received bladder microbiota transplantation; f)Be conscious and able to communicate in language normally. Bladder bacteria donors a)Healthy female, aged 18-30 years, with no bacterial or fungal infectious diseases of the bladder in the past 1 year, healthy work and rest, no bad living habits such as staying up late, and no use of antibiotics, probiotics or immunomodulators in the past 6 months; b)No history of drug and food allergy, no history of long-term medication; c)No underlying diseases, autoimmune diseases, parasitic infections and other disease states.

Exclusion criteria

Exclusion criteria: a)Suffering from severe cardiovascular and cerebrovascular diseases, respiratory system diseases, immune system diseases and severe liver and kidney damage; b)Suffering from severe mental illness, such as depression, generalized anxiety disorder, etc.; c)Patients with bladder tumor; d)Patients with allergic reactions to the treatment of bladder microbiota transplantation; e)Patients who fail to provide complete medical history or examination data; f)Unable to carry out this study due to various reasons, various tests are needed; g)Fever, pregnancy, lactation, severe systemic infection, etc. h)Use of antibiotics in the past 2 weeks; i)Use of probiotics or immunomodulators in the past 1 month.

Design outcomes

Primary

MeasureTime frame
Renal function;Urine analysis;16S rRNA sequence;Questionnaire;Urinary IgA;Amplification and quantitative culture of urine and feces were performed;Mass spectrum identification;Metagenome;Cystoscopy;

Secondary

MeasureTime frame
Glycosylated hemoglobin;Blood lgA;C-reactive protein;Liver function;Endotoxin;Infectious disease indicators;

Countries

China

Contacts

Public ContactFeng Ninghan

Wuxi No.2 People's Hospital

fnh888@njmu.edu.cn+86 138 1395 2696

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026