Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Recruiting Observational

Washed Microbiota Transplantation for Clostridioides Difficile Infection

NCT06106698 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2023-07-22
Last updated
2023-10-30

Condition(s) studied

Clostridioides Difficile Infection

Investigational drug(s) / intervention(s)

WMT

WMT: Washed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive one dose of WMT for CDI. During follow-up, those who have non-response or CDI recurrence within 4-week post-WMT will receive rescue WMT.

Study summary

This is a real-world study to explore the safety and the efficacy of washed microbiota transplantation (WMT) for patients with Clostridioides Difficile Infection (CDI).

Eligibility

Sex
ALL
Min age
3 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to enter the study: 1. At the time of informed consent, male or non-pregnant or non-lactating female. 2. The diagnostic criteria for C. difficile infection are met during screening: 1. Medical records confirming CDI prior to screening (laboratory tests are positive for Clostridium difficile or its toxin): Clostridium difficile toxin test is positive (determined by EIisa test), or colonoscopy indicates pseudomembranous enteritis; Or Glutamate dehydrogenase positive, toxin negative, there are obvious causes and diarrhea. 2. CDI-related diarrhea episodes, i.e., defecation ≥3 times/day for at least two consecutive days with unformed stools (Bristol score 6-7). 3. The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study. Exclusion Criteria: Subjects meeting any of the following exclusion criteria must be excluded from the study: 1. Subjects with immune deficiencies (such as HIV infection, or neutrophils \<0.5×109/L in absolute value, or lymphocytes \<0.5×109/L, etc.), or on immunosuppressants, or on medium to high doses of steroid hormones (≥20g/d of prednisone or equal doses of steroid hormones). 2. There is rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis assessed by the investigator and colonic transendoscopic enteral tubing cannot be performed. 3. Confirmed or clinically suspected infection with pathogenic microorganisms other than Clostridium difficile prior to screening. 4. Have had major abdominal surgery (other than laparoscopic gallbladder or appendectomy), previous partial or total colectomy, previous partial small intestinal resection, or previous gastroduodenal surgery within 6 months prior to screening. 5. At the time of screening, the subject or his/her legal representative refuses to take effective contraception within 3 months after the last treatment. 6. According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.

Primary outcome measure(s)

  • The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 — Four-week post-WMT
    The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).

Trial sites (1)

FacilityCityRegionStatus
The second affiliated hospital of Nanjing Medical University Nanjing Jiangsu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06106698 on ClinicalTrials.gov ↗ ← All trials in China