Fecal Transplant for C Diff Infection

Overseen By Sandarsh Kancherla, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Englewood Hospital and Medical Center

Disqualifiers: Pregnancy, Non-compliance, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called Fecal Microbiota Transplantation (FMT) for individuals with recurrent Clostridium difficile infections (CDI), which are challenging gut infections. The treatment introduces healthy bacteria from a donor's stool into a patient's gut to combat the harmful bacteria causing the infection. Individuals who have experienced multiple CDI episodes that do not respond to standard antibiotics might be suitable candidates for this trial. The researchers aim to determine if this method reduces infection recurrence and improves gut health. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance treatment options for persistent gut infections.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves treating recurrent or severe C. difficile infections, it's possible that you may need to continue certain antibiotics as part of your treatment plan.

What prior data suggests that this method is safe for treating C Diff infection?

Research has shown that fecal microbiota transplantation (FMT) is a safe treatment for people with recurring C. diff infections. Studies indicate that FMT is generally well-tolerated, with few serious side effects. In one study, patients who received FMT did not experience severe negative reactions, and the treatment effectively prevented further infections. Another study found that FMT is safe even for people with weakened immune systems. Overall, FMT has a strong safety record for treating C. diff infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard antibiotic treatments for C. diff infection, which primarily target the bacteria, fecal transplant therapy offers a unique approach by using human fecal matter to restore the natural balance of gut bacteria. This method introduces a diverse range of healthy bacteria, which can outcompete C. diff and help re-establish a healthy microbiome. Researchers are excited about fecal transplants because they have the potential to quickly and effectively reduce infection recurrence, offering hope for patients who have not responded well to traditional antibiotics.

What evidence suggests that Fecal Microbiota Transplantation is effective for Clostridium difficile infection?

Research has shown that fecal microbiota transplantation (FMT) safely and effectively treats recurring Clostridioides difficile infection (CDI). Studies have found that FMT restores healthy gut bacteria, which can combat harmful C. difficile bacteria. The beneficial bacteria from the donor's stool produce substances that kill C. difficile and prevent it from adhering to the colon. Methods such as colonoscopy and enema have proven this treatment effective. Overall, FMT is recognized as a successful option for managing and reducing CDI symptoms. Participants in this trial will receive 150-500 ml of human fecal matter as part of the experimental treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Marc Fiorillo, MD

Principal Investigator

Englewood Hospital and Medical Center

Are You a Good Fit for This Trial?

This trial is for adults who've had multiple severe Clostridium difficile infections (CDI) that led to hospital stays or didn't respond to standard treatments like vancomycin. Participants must be able to give informed consent and, if they can have children, agree to use birth control for up to 4 weeks after treatment. Pregnant individuals or those unable to follow the study plan cannot join.

Inclusion Criteria

At least two episodes of severe CDI resulting in hospitalization and associated with significant morbidity

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)

Exclusion Criteria

Subject is pregnant

Subject is unable to comply with study requirements

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 (FMT) via colonoscopy, sigmoidoscopy, or retention enema

1 day

1 visit (in-person)

Follow-up

Participants are monitored for CDI recurrence and safety for 8 weeks post FMT

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Human fecal matter

Trial Overview The trial tests Fecal Microbiota Transplantation (FMT), where stool from a healthy donor mixed with saline is infused into the patient's bowel via colonoscopy, sigmoidoscopy, or enema. The method depends on individual needs and physician discretion. The goal is for good bacteria in the transplant to fight off CDI by killing C. difficile and blocking its toxins.

How Is the Trial Designed?

Group I: All patients Experimental Treatment 1 Intervention

150-500 ml of human fecal matter

Who Is Running the Clinical Trial?

Englewood Hospital and Medical Center

Lead Sponsor

Trials

21

Recruited

770+

Published Research Related to This Trial

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]

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) 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34864789/

Outcomes of Fecal Microbiota Transplantation for C. difficile ... Fecal microbiota transplantation (FMT) is a safe and effective therapy for recurrent Clostridioides difficile infection (CDI). Data on FMT ...

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 ... Suchman, K.I. ∙ Luo, Y. ∙ Grinspan, A.M.. Fecal microbiota transplant for Clostridioides difficile infection in an immunocompromised population.

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

A Randomized Controlled Trial of Efficacy and Safety ... The aim of our randomized, double-blind clinical trial was to assess the efficacy of capsule-delivered fecal microbiota transplant (FMT) versus placebo in ...

5. cidrap.umn.edu cidrap.umn.edu/clostridium-difficile/study-highlights-optimal-strategies-fecal-transplantation-c-diff-patients

Study highlights optimal strategies for fecal transplantation ... Danish researchers report that fecal microbiota transplantation (FMT) was most effective against Clostridioides difficile infection (CDI) when administered as ...

6. cidrap.umn.edu cidrap.umn.edu/clostridium-difficile/australian-study-highlights-safety-efficacy-fecal-microbiota-transplants-c

Australian study highlights safety, efficacy of fecal ... A real-world study of patients with Clostridioides difficile infection (CDI) in Australia over 10 years shows that fecal microbiota transplantation (FMT) ...