Fecal Microbiota Transplant for Clostridium Difficile Colitis

Overseen By Gary M Cox, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Duke University

Must not be taking: Antibacterials

Disqualifiers: Neutropenia, Active infection, Chemotherapy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 5

Duration: 1 day

77 Participants Needed

Trial Summary

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?

Research shows that fecal microbiota transplant (FMT) is highly effective for treating recurrent Clostridium difficile infection, with cure rates over 90% and reduced recurrence compared to antibiotics. It is also promising for severe cases, potentially lowering death and surgery rates. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 5 11 12}

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.

Research Team

Gary M Cox, MD

Principal Investigator

Duke University

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.

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

Trial Overview The 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

Group I: fecal microbiota transplantation Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

Fecal microbiota transplantation (FMT) was found to be a safe and effective treatment for recurrent Clostridium difficile infection (R-CDI) in a study of 13 patients, achieving an overall resolution rate of 91.7%.

The novel approach of administering FMT via oral capsules resulted in a 100% resolution rate, suggesting that this method could facilitate wider use of FMT in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation for recurrent Clostridium difficile infection: Experience, protocol, and results. Reigadas, E., Olmedo, M., Valerio, M., et al.[2020]

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]

In a study of 9 patients with severe and complicated Clostridium difficile infection (CDI) who were at risk of needing colectomy, fecal microbiota transplant (FMT) resulted in a 78% cure rate after just one treatment, demonstrating its efficacy as an alternative therapy.

Following FMT, 88.88% of patients were able to avoid colectomy during their hospital stay, indicating that FMT could be a valuable bowel-saving intervention in critical cases of CDI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of fecal microbiota transplant in 9 critically ill patients with severe and complicated Clostridium difficile infection with impending colectomy. Alukal, J., Dutta, SK., Surapaneni, BK., et al.[2020]

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]

Fecal microbiota transplantation (FMT) shows high effectiveness in treating recurrent Clostridium difficile infections (CDI), with clinical success rates between 83% and 100% based on various studies, including randomized controlled trials.

FMT is generally safe, with major adverse events being rare; however, common side effects like diarrhea, cramping, and bloating are usually mild and self-limiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplant in patients with Clostridium difficile infection: A systematic review. Chapman, BC., Moore, HB., Overbey, DM., et al.[2022]

Fecal microbiota transplantation (FMT) is a safe and effective treatment for recurrent Clostridioides difficile infections, highlighting its importance in clinical practice.

The selection of fecal microbiota donors is crucial for ensuring the safety of recipients, prompting the establishment of protocols and recommendations by a multidisciplinary group in Cataluña to minimize risks associated with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Aira, A., Arajol, C., Casals-Pascual, C., 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]

In a long-term follow-up study of 84 patients (45 receiving faecal microbiota transplantation (FMT) and 39 receiving antibiotics), FMT was found to be a safe and effective treatment for recurrent C. difficile infection, with no significant differences in severe disease incidence between the two groups over an average of 3.8 years.

Patients who received FMT reported significantly faster improvements in bowel habits and better mental health compared to those treated with antibiotics, indicating that FMT may offer additional benefits beyond just treating the infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The long-term effects of faecal microbiota transplantation for gastrointestinal symptoms and general health in patients with recurrent Clostridium difficile infection. Jalanka, J., Hillamaa, A., Satokari, R., et al.[2022]

In a follow-up survey of 137 patients who received fecal microbiota transplant (FMT) for recurrent Clostridium difficile infection (RCDI), 82% reported no recurrence of CDI at a median follow-up of 22 months, indicating FMT's long-term efficacy.

Despite the high success rate, 33% of patients reported new medical conditions or symptoms post-FMT, but 95% expressed willingness to undergo the procedure again, highlighting patient satisfaction with FMT as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durability and Long-term Clinical Outcomes of Fecal Microbiota Transplant Treatment in Patients With Recurrent Clostridium difficile Infection. Mamo, Y., Woodworth, MH., Wang, T., 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]

A survey of 135 physicians revealed that only 20% had treated a patient with fecal microbiota transplantation (FMT) for recurrent Clostridium difficile infection, indicating limited adoption of this effective therapy despite its safety and efficacy.

Many physicians believe that patients would find FMT unappealing and have concerns about the clinical appropriateness of the treatment, leading to a significant gap between physician attitudes and potential patient acceptance of FMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician attitudes toward the use of fecal microbiota transplantation for the treatment of recurrent Clostridium difficile infection. Zipursky, JS., Sidorsky, TI., Freedman, CA., et al.[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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation for recurrent Clostridium difficile infection: Experience, protocol, and results. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation: Redefining Surgical Management of Refractory Clostridium difficile Infection. [2021]

3. Australia pubmed.ncbi.nlm.nih.gov

Safety and efficacy of fecal microbiota transplant in 9 critically ill patients with severe and complicated Clostridium difficile infection with impending colectomy. [2020]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplant in patients with Clostridium difficile infection: A systematic review. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

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]

7. China pubmed.ncbi.nlm.nih.gov

[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. [2020]

8. England pubmed.ncbi.nlm.nih.gov

The long-term effects of faecal microbiota transplantation for gastrointestinal symptoms and general health in patients with recurrent Clostridium difficile infection. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Durability and Long-term Clinical Outcomes of Fecal Microbiota Transplant Treatment in Patients With Recurrent Clostridium difficile Infection. [2022]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation: Is It Safe? [2021]

11. Egypt pubmed.ncbi.nlm.nih.gov

Physician attitudes toward the use of fecal microbiota transplantation for the treatment of recurrent Clostridium difficile infection. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

A Practical Method for Preparation of Fecal Microbiota Transplantation. [2020]