Actively Recruiting

Age: 3Years - 100Years
All Genders
NCT06106698

Washed Microbiota Transplantation for Clostridioides Difficile Infection

Led by The Second Hospital of Nanjing Medical University · Updated on 2023-10-30

100

Participants Needed

1

Research Sites

332 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Washed Microbiota Transplantation for Clostridioides Difficile Infection

Who Can Participate

Age: 3Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or non-pregnant, non-lactating female at time of consent
  • Diagnosed with Clostridioides Difficile Infection confirmed by positive toxin test, colonoscopy, or related criteria
  • Experiencing CDI-related diarrhea with at least 3 bowel movements per day for 2 consecutive days with unformed stools (Bristol score 6-7)
  • Able to understand the study, communicate with the investigator, and comply with study requirements
  • Provides informed consent
Not Eligible

You will not qualify if you...

  • Immune deficiencies such as HIV or low neutrophils or lymphocytes, or taking immunosuppressants or medium to high doses of steroids (≥20g/day prednisone or equivalent)
  • Rectal outlet obstruction or significant intestinal narrowing preventing colonic enteral tubing
  • Infection with other pathogenic microorganisms besides Clostridium difficile
  • Major abdominal surgery (except laparoscopic gallbladder or appendectomy), partial or total colectomy, partial small intestinal resection, or gastroduodenal surgery within 6 months
  • Refusal to use effective contraception within 3 months after last treatment
  • Investigator judges participant unsuitable or participation would not protect their rights and interests

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The second affiliated hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210011

Actively Recruiting

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Research Team

F

Faming Zhang, PhD

CONTACT

B

Bota Cui

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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