Fecal Microbiota Transplant for Clostridium Difficile Colitis

Recruiting in Palo Alto (17 mi)

Overseen by Gary 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?

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}

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.

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 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 Canada for the following indications:

Approved in Canada as Fecal Microbiota Transplantation for:

• Recurrent Clostridioides difficile (C. diff) infection

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Duke University Medical Center Durham, NC

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2495

Patients 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]

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]

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]

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]

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]

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]

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]

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]

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. China pubmed.ncbi.nlm.nih.gov

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

7. 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]

8. 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]

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]