Efficacy and Safety of Standardized Fecal Microbiota Transplantation for Moderate to Severe Crohn's Diseases

Who is this study for? Patients with Crohn's Disease
What treatments are being studied? Fecal Microbiota Transplantation
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Clinical diagnosis of Crohn's disease, with the diagnosis remaining unchanged after at least three months of follow-up.

• Willingness to undergo FMT (Fecal Microbiota Transplantation).

Locations
Other Locations
China
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
RECRUITING
Huai'an
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Faming Zhang, MD, PhD
fzhang@njmu.edu.cn
86-025-58509883
Backup
Huijie Zhang, MD, PhD
zhjssm@163.com
86-025-58509670
Time Frame
Start Date: 2013-02
Estimated Completion Date: 2025-12
Participants
Target number of participants: 800
Treatments
Experimental: Fecal microbiota transplantation
Standard fecal microbiota transplantation, which has been defined as washed microbiota transplantation since 2019.
No_intervention: Traditional treatments
Traditional treatments for Crohn's disease and its complications according to the guidelines.
Related Therapeutic Areas
Sponsors
Collaborators: The First Affiliated Hospital of Air Force Medicial University, The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University
Leads: The Second Hospital of Nanjing Medical University

This content was sourced from clinicaltrials.gov

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