Fecal Microbiota Transplantation for C. diff Infection

Overseen By Anne Foley

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Krunal Patel

Disqualifiers: Age <16, Acute colonic dilation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a stool transplant, also known as Fecal Microbiota Transplantation (FMT), can treat recurring C. diff infections, which affect the colon and cause severe diarrhea and abdominal pain. The procedure involves transferring healthy bacteria from a donor's stool into the colon of someone with a C. diff infection. The goal is to restore good bacteria in the gut and reduce the chance of the infection returning. Individuals who have experienced C. diff infections twice or more, despite treatment, might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore new treatment possibilities for recurring C. diff infections.

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 prior data suggests that this procedure is safe for treating C. diff infection?

Research has shown that fecal microbiota transplantation (FMT) is generally safe for treating recurrent C. diff infections. FMT involves transferring healthy bacteria from a donor's stool to a patient's colon and has a strong safety record.

One study found no major differences in side effects between patients who received FMT and those who received a placebo, indicating that serious side effects are rare. Additionally, FMT is primarily used for persistent C. diff infections and has proven effective without major safety concerns.

Overall, FMT is considered well-tolerated, with reports of serious problems being uncommon. However, like any medical treatment, risks may exist, so discussing these with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fecal Microbiota Transplantation (FMT) is unique because it introduces healthy bacteria from donor stool directly into the colon, which can effectively restore balance to the gut microbiome. Unlike traditional antibiotics, which often target and kill bacteria indiscriminately, FMT specifically replenishes beneficial bacteria that can combat C. diff infections. Researchers are excited about this treatment because it has the potential to be more effective in preventing recurrent infections and may offer a quicker recovery with fewer side effects compared to the standard antibiotic treatments.

What evidence suggests that fecal microbiota transplantation is effective for C. diff infection?

Studies have shown that fecal microbiota transplantation (FMT), which participants in this trial will receive, effectively treats repeat C. diff infections. Research indicates that FMT restores healthy bacteria in the colon, preventing the infection from recurring. Clinical guidelines suggest using FMT after two or more C. diff infections. In past studies, patients who received FMT achieved a high success rate in stopping the infection. This treatment works well, even in people with weakened immune systems. ^{1 2 3 4 6}

Who Is on the Research Team?

Krunal Patel

Principal Investigator

UMass Medical School

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Fecal Microbiota Transplantation

Trial Overview 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.

How Is the Trial Designed?

Group I: Fecal Microbiota Transplantation Experimental Treatment 1 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)

Who Is Running the Clinical Trial?

Krunal Patel

Lead Sponsor

Trials

1

Recruited

500+

Published Research Related to This Trial

Fecal Microbiota Transplantation (FMT) has shown high efficacy rates (68% to 93%) in treating recurrent Clostridium difficile infections, particularly in elderly patients with multiple health issues and in younger individuals with inflammatory bowel disease.

The procedure is generally safe, with only minor side effects reported, such as fever and abdominal discomfort, and no significant increase in the incidence of other diseases, indicating a favorable safety profile for FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplant in Recurrent Clostridium Difficile Infections: A Systematic Review. Gupta, K., Tappiti, M., Nazir, AM., et al.[2022]

Fecal microbiota transplantation (FMT) is recommended for treating recurrent Clostridium difficile infections and has shown benefits for various gastrointestinal disorders, but safety data is still limited due to the rapid adoption of the technique without extensive long-term studies.

Capsulized FMT therapy offers a promising solution for long-term maintenance and reduces the need for invasive procedures, indicating a shift towards safer and more tolerable methods of delivering FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. Li, N., Tian, H.[2020]

Fecal microbiota transplantation (FMT) is a cost-effective treatment for recurrent Clostridium difficile infection (rCDI), with all economic evaluations showing it to be more cost-effective than other standard treatments at a threshold of ≤$50,000 per quality-adjusted life year (QALY).

The systematic review included 9 high-quality economic evaluations, primarily focusing on rCDI and inflammatory bowel disease (IBD), indicating that while FMT is effective for rCDI, further studies are needed to explore its economic impact for other conditions like IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of economic evaluation in fecal microbiota transplantation. Stalder, T., Kapel, N., Diaz, S., et al.[2021]

In a study of 35 patients with recurrent C. difficile infection, 85.7% experienced resolution of their symptoms within 6-8 weeks after undergoing fecal microbiota transplantation (FMT), indicating its effectiveness as a treatment option.

Among patients with a history of inflammatory bowel disease, 75% reported symptom resolution post-FMT, suggesting that FMT may also be beneficial for this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in recurrent Clostridium difficile infection: A retrospective single-center chart review. Kim, P., Gadani, A., Abdul-Baki, H., et al.[2022]

Fecal microbiota transplantation (FMT) has a cure rate of over 90% for recurrent Clostridioides difficile infection (CDI) and is more effective than antibiotics in preventing recurrence.

Emerging evidence suggests that FMT is beneficial for severe and fulminant CDI, potentially reducing mortality and the need for colectomy, and should be considered early in treatment for critically-ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation: Redefining Surgical Management of Refractory Clostridium difficile Infection. Cheng, YW., Fischer, M.[2021]

Fecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridioides difficile infection and has become more accessible due to the availability of stool banks.

Recent studies suggest that FMT may also be beneficial for other conditions like ulcerative colitis, irritable bowel syndrome, and hepatic encephalopathy, indicating its potential for broader therapeutic applications, although more research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Application and Potential of Fecal Microbiota Transplantation. Ooijevaar, RE., Terveer, EM., Verspaget, HW., et al.[2022]

Out of 114 evaluated donor candidates for fecal microbiota transplantation (FMT), only 29 (25%) qualified as stool donors after a rigorous four-step screening process, highlighting the challenges in donor recruitment.

The screening process resulted in a total of 127 usable stool aliquots, but 15 samples were excluded after further testing, indicating the importance of thorough testing to ensure safety and efficacy in FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Donor program for fecal microbiota transplantation: A 3-year experience of a large-volume Italian stool bank. Ianiro, G., Porcari, S., Bibbò, S., et al.[2021]

Fecal microbiota transplantation (FMT) is a generally safe and well-tolerated procedure for treating recurrent Clostridioides difficile infections, even in high-risk patients, with most short-term risks being mild and related to delivery methods.

Recent concerns have emerged regarding serious adverse events linked to FMT products from stool banks that do not screen for multi-drug resistant organisms, highlighting the need for improved safety protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation: Is It Safe? Park, SY., Seo, GS.[2021]

Fecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridium difficile infections, helping to restore healthy gut bacteria and resolve symptoms.

The chapter presents a rapid and cost-effective method for preparing FMT using simple, disposable materials, making the procedure more accessible for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Practical Method for Preparation of Fecal Microbiota Transplantation. Perez, E., Lee, CH., Petrof, EO.[2020]

In 2018, OpenBiome, a large stool bank, processed 4,271 fecal microbiota transplants (FMT) from 7,536 donations, indicating a robust system for providing FMT material to treat recurrent Clostridioides difficile infections.

The median time from donation to shipment of FMT preparations was 8.9 months, highlighting the need for improved efficiency in the stool banking process to enhance patient access to this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stool Banking for Fecal Microbiota Transplantation: Methods and Operations at a Large Stool Bank. Chen, J., Zaman, A., Ramakrishna, B., et al.[2021]

Fecal microbiota transplantation (FMT) significantly reduces the recurrence of Clostridium difficile infection (CDI) in patients, according to a mathematical model based on data from hospitals in the southeastern United States.

While FMT helps prevent recurrent CDI, it does not lower the overall incidence of new cases, indicating that additional strategies are needed to prevent transmission of the infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mathematical model to evaluate the routine use of fecal microbiota transplantation to prevent incident and recurrent Clostridium difficile infection. Lofgren, ET., Moehring, RW., Anderson, DJ., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39271107/

A Randomized Controlled Trial of Efficacy and Safety of ... ... Fecal Microbiota Transplant for Preventing Recurrent Clostridioides difficile Infection ... Fecal Microbiota Transplantation* / adverse effects ...

2. ccjm.org ccjm.org/content/92/7/421

Fecal microbiota transplantation: Current evidence and ... Fecal microbiota transplantation (FMT), a well-established procedure, is recognized for effectively treating recurrent Clostridioides difficile infection.

3. cghjournal.org cghjournal.org/article/S1542-3565(25)00646-9/abstract

Effectiveness and Safety of Fecal Microbiota ... Effectiveness and Safety of Fecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection in Immunocompromised Patients.

4. jwatch.org jwatch.org/na57994/2024/11/06/fecal-microbiota-transplantation-recurrent-c-difficile

Fecal Microbiota Transplantation for Recurrent C. difficile ... Clinical guidelines recommend fecal microbiota transplantation (FMT) following two or more recurrences of Clostridioides difficile infection (CDI).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9946715/

Fecal Microbiota Transplantation - PMC Fecal microbiota transplantation for treatment of patients with recurrent Clostridioides difficile infection . Expert Rev Anti Infect Ther. 2020;18(07):669 ...

6. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/fecal-transplant

Fecal Transplant FMT is mainly used to treat persistent infections with C. diff. The procedure works by taking healthy bacteria (microbiota) from the feces of a carefully ...