Fecal Microbiota Transplantation for Clostridium Difficile Infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to treat patients with recurrent or refractory Clostridium difficile infection (CDI) using Fecal Microbiota Transplantation (FMT). The procedure involves infusing a mixture of saline and stool from a healthy donor into the patient's bowel during a colonoscopy. This method leverages beneficial bacteria to combat CDI by producing substances that kill the bacteria and preventing its toxins from attaching to the colon lining. The delivery method may vary based on individual patient characteristics and physician discretion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject is at least 18 years old.
2. Subject has recurrent or relapsing CDI defined as:

   * At least three episodes of mild-to-moderate CDI and failure of a 6-8 week taper with vancomycin with or without an alternative antibiotic (e.g., rifaximin, nitazoxanide, fidaxomicin). OR
   * At least two episodes of severe CDI resulting in hospitalization and associated with significant morbidity. OR
   * Moderate CDI not responding to standard therapy (vancomycin) for at least a week. OR
   * Severe C. difficile infection with toxic megacolon, not responding to standard therapy or the use of IVIg.
3. Subject is willing and able to provide informed consent.
4. If a female of childbearing potential, subject has agreed to use an acceptable form of birth control for up to 4 weeks after FMT treatment.

Exclusion Criteria:

1. Subject is pregnant.
2. Subject is unable to comply with study requirements.

Where it's running

• Englewood Hospital and Medical Center
  Englewood, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Marc Fiorillo, MD — Englewood Hospital and Medical Center
• Study coordinator: Marc Fiorillo, MD
• Email: fiorillomd@gmail.com
• Phone: 201-945-6564

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.