Actively Recruiting
Fecal Microbiota Transplantation for the Treatment of Recurrent or Refractory Clostridium Difficile Infection (CDI)
Led by Englewood Hospital and Medical Center · Updated on 2025-04-13
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Fecal Microbiota Transplantation (FMT) to treat patients with recurrent or hard-to-treat Clostridium difficile infection (CDI). The study explores how healthy donor stool bacteria can fight Clostridium difficile by producing substances that kill the bacteria and preventing its toxins from attaching to the colon lining. This treatment aims to address cases where standard therapies have failed or CDI has recurred multiple times. Participants receive FMT through methods chosen based on their individual health and physician judgment. The stool mixture is infused into the colon using colonoscopy, sigmoidoscopy, or retention enema. Colonoscopy allows full colon examination and delivers 300-500 mL of stool suspension at the furthest insertion point. Sigmoidoscopy and retention enema are alternative methods with different volumes and may be preferred depending on patient condition and tolerance. During the study, participants will undergo the FMT procedure and are encouraged to retain the stool for as long as possible. Researchers will monitor for recurrence of CDI over 8 weeks as the primary outcome. The study involves assessments related to treatment response and safety, with ongoing monitoring to understand the effectiveness of FMT in preventing CDI relapse. Participation duration varies based on follow-up visits and evaluations.
CONDITIONS
Brief Title
Fecal Microbiota Transplantation for C Diff Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is at least 18 years old.
- Subject has recurrent or relapsing CDI defined as at least three episodes of mild-to-moderate CDI with failure of a 6-8 week vancomycin taper, or at least two episodes of severe CDI requiring hospitalization, or moderate CDI not responding to standard therapy for at least a week, or severe CDI with toxic megacolon not responding to therapy or IVIg.
- Subject is willing and able to provide informed consent.
- Female subjects of childbearing potential agree to use birth control for up to 4 weeks after treatment.
You will not qualify if you...
- Subject is pregnant.
- Subject is unable to comply with study requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment with follow-up through 8 weeks
Participants receive a transplantation of human fecal matter as treatment for recurrent or refractory Clostridium difficile infection.
1 treatment visit and periodic follow-up visits during 8 weeks
Trial Site Locations
Total: 1 location
1
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
Actively Recruiting
Research Team
M
Marc Fiorillo, MD
R
Rosabel Cascina
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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