Fecal Microbiota Transplant for Clostridium Difficile Colitis
Recruiting in Palo Alto (17 mi)
Overseen byGary M Cox, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Duke University
Must not be taking: Antibacterials
Disqualifiers: Neutropenia, Active infection, Chemotherapy, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
It has been shown that restoration of the normal makeup of the bowel bacterial population is the most effective way to treat recurrent colitis due to Clostridium difficile. Restoration of the normal bowel bacterial population is best done by transplanting stool from a healthy donor. The investigators wish to transplant stool from healthy donors to treat recurrent C. difficile colitis by incorporating the stool into capsules that are administered by the oral route.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have an active infection requiring ongoing antibacterial therapy, you may not be eligible to participate.
What data supports the effectiveness of the treatment Fecal Microbiota Transplant for Clostridium Difficile Colitis?
Is fecal microbiota transplantation (FMT) safe for humans?
FMT is generally considered safe and well-tolerated, even in high-risk patients, with most short-term risks being mild and related to delivery methods. However, long-term side effects are not well-established, and serious adverse events have been associated with inadequate donor screening for multi-drug resistant organisms.678910
How is fecal microbiota transplantation different from other treatments for Clostridium difficile infection?
Fecal microbiota transplantation (FMT) is unique because it involves transplanting stool from a healthy donor to restore healthy bacteria in the gut, achieving cure rates over 90% for recurrent infections, which is higher than standard antibiotic treatments. It is particularly effective for severe cases and can reduce the need for surgery and lower mortality rates.1251112
Eligibility Criteria
This trial is for adults over 18 who've had at least three episodes of C. difficile colitis in the past year. It's not for those with very low white blood cell counts, tube feedings, pregnant women, short life expectancy, trouble swallowing pills, certain stomach surgeries or conditions requiring IV nutrition, other active infections needing antibiotics, recent chemotherapy, inflammatory bowel diseases like Crohn's or ulcerative colitis, or untreated intestinal parasites.Inclusion Criteria
I am over 18 and have had 3 or more C. difficile infections in the last year.
Exclusion Criteria
I have been diagnosed with an inflammatory bowel disease.
I cannot swallow pills.
I am not on antibiotics for an infection other than C. difficile.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive fecal microbiota transplantation via encapsulated stool administered orally during a single outpatient clinic visit
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with visits on days 1, 7, 28, and 180
6 months
4 visits (in-person)
Treatment Details
Interventions
- Fecal Microbiota (Fecal Microbiota Transplantation)
Trial OverviewThe trial is testing stool transplants to treat stubborn C. difficile colitis. Healthy donor stool is made into capsules that participants take by mouth to restore normal bacteria in their bowels and combat the infection.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: fecal microbiota transplantationExperimental Treatment1 Intervention
fecal microbiota transplantation
Fecal Microbiota is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Fecal Microbiota Transplantation for:
- Recurrent Clostridioides difficile (C. diff) infection
🇪🇺 Approved in European Union as Fecal Microbiota Transplantation for:
- Recurrent Clostridioides difficile (C. diff) infection
🇨🇦 Approved in Canada as Fecal Microbiota Transplantation for:
- Recurrent Clostridioides difficile (C. diff) infection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University Medical CenterDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
References
Fecal microbiota transplantation for recurrent Clostridium difficile infection: Experience, protocol, and results. [2020]Fecal microbiota transplantation (FMT) is a highly effective therapy for recurrent Clostridium difficile infection (R-CDI). Despite its excellent efficacy, it is still not a routine procedure in most European centers. FMT has not been widely used in Spain to date. We describe our experience with FMT, including a novel approach based on oral fecal capsules.
Fecal Microbiota Transplantation: Redefining Surgical Management of Refractory Clostridium difficile Infection. [2021]Fecal microbiota transplantation (FMT) is the process of transplanting stool from a healthy donor into the gut of a diseased individual for therapeutic purposes. It has a clearly defined role in the treatment of recurrent Clostridium difficile (reclassified as " Clostridioides difficile ") infection (CDI), with cure rates over 90% and decreased rates of subsequent recurrence compared with anti-CDI antibiotics. There is emerging evidence that FMT is also effective in the treatment of severe and fulminant CDI, with associated decreases in mortality and colectomy rates compared with standard antibiotic therapy. FMT shows promise as salvage therapy for critically-ill CDI patients refractory to maximum medical therapy and not deemed to be surgical candidates. FMT should be considered early in the course of severe CDI and should be delivered immediately in patients with signs of refractory CDI. Expansion of FMT's use along the spectrum of CDI severity has potential to decrease associated rates of mortality and colectomy.
Safety and efficacy of fecal microbiota transplant in 9 critically ill patients with severe and complicated Clostridium difficile infection with impending colectomy. [2020]Significant data support the efficacy and safety of fecal microbiota transplant (FMT) in recurrent Clostridium difficile infection (CDI). The objective of our study was to determine the success rate of FMT in patients diagnosed with severe and complicated CDI with impending colectomy in the intensive care setting.
A mathematical model to evaluate the routine use of fecal microbiota transplantation to prevent incident and recurrent Clostridium difficile infection. [2022]Fecal microbiota transplantation (FMT) has been suggested as a new treatment to manage Clostridium difficile infection (CDI). With use of a mathematical model of C. difficile within an intensive care unit (ICU), we examined the potential impact of routine FMT.
Fecal microbiota transplant in patients with Clostridium difficile infection: A systematic review. [2022]Fecal microbiota transplantation (FMT) restores a diverse bacterial profile to the gastrointestinal tract and may effectively treat patients with Clostridium difficile infection (CDI). The objective of this systematic review was to evaluate the effectiveness of FMT in the treatment of CDI.
[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. [2020]Fecal microbiota transplantation (FMT), also known as fecal bacteriotherapy or fecal infusion, consists of injection of a liquid filtrate of feces from a healthy donor into the gastrointestinal tract of a recipient individual. FMT has been proposed as a therapeutic approach for functional diseases of the gastrointestinal tract by reestablishment of a wide diversity of intestinal flora. Clostridium difficile infection (CDI) treatment guideline from American Gastroenterology Association (AGA) recommends that FMT can be used as the treatment protocols of relapse CDI. Numerous case reports, retrospective case series, and randomized controlled trials have shown the benefit of FMT in patients with functional bowel disorders, including inflammatory bowel disease, irritable bowel syndrome and constipation, etc. Evidence regarding the safety of FMT is relatively limited because the very rapid adoption of FMT as a therapeutic modality for CDI occurred before the performance of large, long prospective trials that are typically conducted to assess the safety of new interventions. Potential adverse events can be categorized as short-term and long-term, and short-term events can further be divided into those related to the method of FMT delivery (colonoscopy, sedation) and those related to the FMT itself. Due to the recent emergence of FMT, little data exist regarding long-term events and many safety concerns are speculative. Capsulized FMT therapy solves the clinical problems associated with the use of fresh FMT suspensions for long-term maintenance i.e. repeat transplantation and invasive procedures, which is of great significance to optimize the traditional FMT clinical strategy. Future work will focus on establishing best practices and more robust safety data than exist currently, as well as refining FMT beyond current "whole-stool" transplants to increase safety and tolerability. Encapsulated formulations, full-spectrum stool-based products, and defined microbial consortia are all in the immediate future. Although challenges exist, regulatory agencies have been willing to work with stakeholders and will continue to evolve and adapt policy as therapeutics based on human gut microbiota research emerge.
The long-term effects of faecal microbiota transplantation for gastrointestinal symptoms and general health in patients with recurrent Clostridium difficile infection. [2022]Faecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridium difficile infection. In short-term the treatment has been shown to be safe, however, there are no large, long-term follow-up studies looking into the potential adverse effects.
Recommendations for stool donor selection for fecal microbiota transplant. Consensus document endorsed by the Catalan Society of Digestology, Catalan Society of Infectious diseases and Clinical Microbiology and the GEMBIOTA group from Spanish Society of Infectious Diseases and Clinical Microbiology. [2022]Fecal microbiota transplantation (FMT) is an effective and safe treatment to treat recurrent Clostridioides difficile infection. It is essential to make every effort to perform FMT rigorously and based on scientific knowledge. Selection of the fecal microbiota donor is a key point of the process to ensure recipient safety. It is necessary to have protocols of action that allow clinicians to act with the maximum guarantees and to minimise the risks of the procedure. For this reason, a multidisciplinary working group has been set up in Cataluña with the aim of establishing recommendations for the selection of the fecal microbiota donor.
Durability and Long-term Clinical Outcomes of Fecal Microbiota Transplant Treatment in Patients With Recurrent Clostridium difficile Infection. [2022]Fecal microbiota transplant (FMT) appears safe and effective for treatment of recurrent Clostridium difficile infection (RCDI). However, durability, long-term clinical outcomes, and patient satisfaction after FMT are not well described.
Fecal Microbiota Transplantation: Is It Safe? [2021]Fecal microbiota transplantation (FMT) is an accepted procedure for the management of recurrent Clostridioides difficile infections. FMT is generally considered safe and well-tolerated - even in high-risk patients. Most short-term risks are mild and known to be associated with delivery methods. Long-term side effects have not been established, and no signs of harm have been found to date. However, causality for several microbiome-associated diseases has to be established. Even though FMT is generally considered safe with strict donor screening, serious adverse events have been recently associated with the FMT product from the stool bank, where screening for multi-drug resistant organisms is not included in protocols. Here, we discuss the adverse events associated with FMT and safety issues.
Physician attitudes toward the use of fecal microbiota transplantation for the treatment of recurrent Clostridium difficile infection. [2021]Fecal microbiota transplantation (FMT) is a safe and effective, yet infrequently used therapy for recurrent Clostridium difficile infection (CDI).
A Practical Method for Preparation of Fecal Microbiota Transplantation. [2020]Clostridium difficile is a challenging infection that can be difficult to treat with antibiotic therapy. This chapter outlines the processing material for fecal microbiota transplantation (FMT), also known as stool transplant. Fecal transplantations are effective in treating recurrent C. difficile infection (CDI). FMT uses a stool sample collected from a healthy, screened donor to restore healthy microbiota in the colon of a patient with CDI for symptom resolution. Here, we describe a rapid method for FMT preparation that uses inexpensive and disposable materials.