Fecal Microbiota Transplantation for Clostridium Difficile Infection
Fecal Microbiota Transplantation for the Treatment of Recurrent or Refractory Clostridium Difficile Infection (CDI)
This study is testing if a treatment using healthy bacteria from a donor's stool can help people with recurring Clostridium difficile infections feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Englewood Hospital and Medical Center Academic / other |
| Locations | 1 site (Englewood, New Jersey) |
| Trial ID | NCT01905709 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with recurrent or relapsing CDI who have not responded to standard antibiotic treatments.
Not a fit: Patients who are pregnant or unable to comply with study requirements will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the recurrence of Clostridium difficile infections in affected patients.
How similar studies have performed: Previous studies have shown that Fecal Microbiota Transplantation can be effective in treating recurrent CDI, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Englewood, New Jersey
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.