Fecal Microbiota Transplantation for C. diff Infection
Recruiting in Palo Alto (17 mi)
Overseen byKrunal Patel
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Krunal Patel
Disqualifiers: Age <16, Acute colonic dilation
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon of the patient with C. diff infection. The goal of this experimental procedure (called fecal microbiota transplantation) is to replenish the good bacteria in the colon that can help prevent C. diff infection from coming back after treatment.
Do I need to stop my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. However, since it involves patients who have failed standard therapy with certain antibiotics, you might need to discuss your current medications with the trial team.
What data supports the effectiveness of the treatment Fecal Microbiota Transplantation for C. diff Infection?
Research shows that Fecal Microbiota Transplantation (FMT) is highly effective for treating recurrent C. difficile infections, with cure rates over 90% and fewer recurrences compared to standard antibiotic treatments. It is also promising for severe cases, reducing the need for surgery and lowering death rates.
12345Is 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. However, long-term side effects are not well-established, and serious adverse events have been linked to inadequate donor screening for drug-resistant organisms.
678910How is fecal microbiota transplantation different from other treatments for C. diff infection?
Fecal microbiota transplantation (FMT) is unique because it involves transplanting stool from a healthy donor to restore the natural balance of bacteria in the gut, which is different from traditional antibiotic treatments. FMT has shown high cure rates and lower recurrence rates for recurrent C. diff infections compared to antibiotics, and it can be particularly effective for severe cases where other treatments have failed.
1351011Eligibility Criteria
This trial is for people who've had at least two recurrences of C. diff infection, with symptoms coming back within 2-8 weeks after treatment. It's also for those whose severe C. diff led to hospitalization and didn't improve with standard antibiotics. Participants must be over 16 and not at risk of colon perforation.Inclusion Criteria
I've been hospitalized for a severe C. diff infection that didn't improve with antibiotics.
I have had C. difficile infection recur at least twice after treatment.
I have tried and not responded to standard treatments like metronidazole or vancomycin.
Exclusion Criteria
I am younger than 16 years old.
I am at risk for a tear in my colon due to severe swelling.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive fecal microbiota transplantation via colonoscopy to treat recurrent Clostridium difficile infection
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after fecal microbiota transplantation
12 months
Periodic visits (in-person)
Participant Groups
The study tests fecal microbiota transplantation (FMT) via colonoscopy to treat recurrent C. diff infections by transferring stool from a healthy donor into the patient's colon, aiming to restore beneficial bacteria.
1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota TransplantationExperimental Treatment1 Intervention
Subjects receive intervention of stool transplanted to the colon via colonoscopy.
Fecal Microbiota Transplantation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Fecal Microbiota Transplantation for:
- Graft-versus-host disease (GVHD)
- Clostridioides difficile infection (CDI)
🇪🇺 Approved in European Union as Fecal Microbiota Transplantation for:
- Graft-versus-host disease (GVHD)
- Clostridioides difficile infection (CDI)
- Other gastrointestinal disorders
🇨🇦 Approved in Canada as Fecal Microbiota Transplantation for:
- Graft-versus-host disease (GVHD)
- Clostridioides difficile infection (CDI)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UMass Memorial Medical CenterWorcester, MA
Loading ...
Who Is Running the Clinical Trial?
Krunal PatelLead Sponsor
References
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.
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 transplantation in recurrent Clostridium difficile infection: A retrospective single-center chart review. [2022]Label="BACKGROUND AND AIM" NlmCategory="OBJECTIVE">Fecal microbiota transplantation (FMT) has been proposed as a treatment option for patients with recurrent Clostridium difficile (C. difficile) infection but remains a novel option. We examined if FMT is an effective means of treating recurrent C. difficile infection.
A systematic review of economic evaluation in fecal microbiota transplantation. [2021]Fecal microbiota transplantation (FMT) is an effective therapy in recurrent Clostridium difficile infection (rCDI). It is only recommended for this indication by European and American guidelines. Other indications of FMT are being studied, such as inflammatory bowel disease (IBD), and they have shown promising results.
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.
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.
[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.
Stool Banking for Fecal Microbiota Transplantation: Methods and Operations at a Large Stool Bank. [2021]Label="Objectives">Fecal microbiota transplantation (FMT) is a recommended therapy for recurrent Clostridioides difficile infection and is being investigated as a potential therapy for dozens of microbiota-mediated indications. Stool banks centralize FMT donor screening and FMT material preparation with the goal of expanding access to FMT material while simultaneously improving its safety, quality, and convenience. Although there are published consensuses on donor screening guidelines, there are few reports about the implementation of those guidelines in functioning stool banks.
Fecal Microbiota Transplant in Recurrent Clostridium Difficile Infections: A Systematic Review. [2022]Fecal Microbiota Transplantation (FMT) is the process of transferring the fecal microbiome from a healthy donor to an individual with repeated multiple episodes of Clostridium difficile infection. It is also known as stool transplant. Fecal microbiota transplant is effective and safe in various studies, the approval from the Food and Drug Administration (FDA) remains pending. The main objective of this systemic review is to evaluate the efficacy and safety of stool transplant in studies with only treatment groups (FMT) and studies with treatment (FMT) and antibiotic (AB) groups and previous studies. Online databases PubMed, PubMed Central, Science Direct, Google Scholar, and Embase were searched for relevant articles in the last five years (2016 to 2021) using automation tools. Following the removal of duplicates, screening of eligibility criteria, titles/abstracts, and quality appraisal were done by two authors independently. In total, seven observational studies are in this review article. Out of the seven observational studies, five are retrospective and two prospective. Two of the five retrospective and one of two prospective studies have a control group. In both the prospective studies and one retrospective study, FMT efficacy of (68% to 93%) was demonstrated in the elderly population despite high index comorbidities. In the younger individuals with inflammatory bowel disease, and efficacy of 90% or above was found. The most common side effects were minor such as fever, abdominal pain, bloating, and flatulence. In one study, two cases of aspiration events occurred attributed to the gastroscopy route of donor feces delivery. There was no statistical significance in the incidence of diseases such as (allergies, autoimmune diseases, cancer, inflammatory bowel diseases, and neurological diseases like dementia and migraine). Fecal microbiota transplantation has shown to be effective and safe in recurrent Clostridium difficile infections. Since very few pragmatic studies have demonstrated its efficacy and safety, their application is not well established. Robust studies, both observation and experiment, are required in the future to well-establish its effectiveness, safety in the treatment of recurrent Clostridium difficile infection.
Donor program for fecal microbiota transplantation: A 3-year experience of a large-volume Italian stool bank. [2021]Due to the increasing rise of C. difficile infection, stool banks and donor programs have been launched to grant access to fecal microbiota transplantation (FMT). Our aim is to describe characteristics and outcomes of the donor program at our stool bank.
Clinical Application and Potential of Fecal Microbiota Transplantation. [2022]Fecal microbiota transplantation (FMT) is a well-established treatment for recurrent Clostridioides difficile infection. FMT has become a more readily available and useful new treatment option as a result of stool banks. The current state of knowledge indicates that dysbiosis of the gut microbiota is implicated in several disorders in addition to C. difficile infection. Randomized controlled studies have shown FMT to be somewhat effective in treating ulcerative colitis, irritable bowel syndrome, and hepatic encephalopathy. In addition, FMT has been beneficial in treating several other conditions, such as the eradication of multidrug-resistant organisms and graft-versus-host disease. We expect that FMT will soon be implemented as a treatment strategy for several new indications, although further studies are needed.