RecruitingNot ApplicableNCT01793831

Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases

Efficacy and Safety of Standardized Fecal Microbiota Transplantation for Moderate to Severe Crohn&Apos;s Diseases


Sponsor

The Second Hospital of Nanjing Medical University

Enrollment

800 participants

Start Date

Feb 1, 2013

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This study tests whether a standardized fecal microbiota transplantation (FMT) — transferring healthy gut bacteria from a donor into a patient — can help treat Crohn's disease, a chronic condition causing inflammation and pain throughout the digestive tract. **You may be eligible if...** - You have been clinically diagnosed with Crohn's disease for at least 3 months - You are willing to undergo the FMT procedure **You may NOT be eligible if...** - You have another serious illness such as cancer, heart or lung failure, or severe liver or kidney disease that makes the procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFMT

Standard FMT


Locations(2)

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

Huai'an, Jiangsu, China

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

Nanjing, Jiangsu, China

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NCT01793831


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