Fecal Microbiota Transplantation for C Diff Infection

Launched by ENGLEWOOD HOSPITAL AND MEDICAL CENTER · Jul 22, 2013

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called Fecal Microbiota Transplantation (FMT) for patients who have repeated or severe Clostridium difficile infections (CDI). CDI is an infection that can cause serious diarrhea and is often hard to treat with regular medications. The idea behind FMT is to use stool from a healthy donor, which contains good bacteria that can help fight off the harmful bacteria causing the infection. The treatment is done during a procedure called a colonoscopy, where the healthy stool is introduced into the patient's colon to help restore a healthy balance of bacteria.

To qualify for this trial, participants must be at least 18 years old and have had multiple episodes of CDI that haven’t improved with standard treatments. Women who can become pregnant need to agree to use birth control for a month after the treatment. If someone joins the trial, they can expect to receive the FMT through different methods depending on their individual health situation. The goal is to help reduce or eliminate their CDI symptoms and improve their overall health.

Gender

ALL

Eligibility 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.