Actively Recruiting

Phase Not Applicable
All Genders
NCT01793831

Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases

Led by The Second Hospital of Nanjing Medical University · Updated on 2024-11-29

800

Participants Needed

2

Research Sites

669 weeks

Total Duration

On this page

Sponsors

T

The Second Hospital of Nanjing Medical University

Lead Sponsor

T

The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using fecal microbiota transplantation (FMT) for Ulcerative Colitis (UC), Crohn's diseases (CD), irritable bowel syndrome (IBS) and constipation have also met with some success. However, the results on CD is very limited. This marks the initial step in exploring the potential efficacy of fecal bacteriotherapy for CD. The investigators aim to evaluate the effectiveness, durability, and safety of FMT in a cohort of at least 500 patients with CD over a ten-year period

CONDITIONS

Official Title

Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of Crohn's disease confirmed after at least three months of follow-up
  • Willingness to undergo fecal microbiota transplantation (FMT)
Not Eligible

You will not qualify if you...

  • Presence of serious conditions such as malignant neoplasms, cardiopulmonary failure, or severe liver or kidney disease that make participation unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

Huai'an, Jiangsu, China, 223000

Actively Recruiting

2

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210011

Actively Recruiting

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Research Team

F

Faming Zhang, MD, PhD

CONTACT

H

Huijie Zhang, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases | DecenTrialz