59 Participants Needed

Fecal Microbiota Transplant for Clostridium Infections

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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, but it excludes those on prolonged antibiotic treatment that affects the gut. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the treatment Autologous Fecal Microbiota Transplantation (Auto-FMT) for Clostridium infections?

Research shows that fecal microbiota transplantation (FMT) is effective for treating recurrent Clostridium difficile infections, with studies indicating it cures nearly 80% of severe cases. This suggests that similar treatments like Auto-FMT could also be effective.12345

Is fecal microbiota transplantation (FMT) safe for humans?

Fecal microbiota transplantation (FMT) is generally considered safe for treating recurrent Clostridium difficile infections, with studies showing it to be effective and safe when performed with proper donor selection and protocols to minimize risks.45678

How is Autologous Fecal Microbiota Transplantation (Auto-FMT) different from other treatments for Clostridium infections?

Autologous Fecal Microbiota Transplantation (Auto-FMT) is unique because it uses the patient's own stool, reducing the risks associated with donor material. This approach is also convenient as it can be administered in capsule form, making it more accessible compared to traditional methods.356910

What is the purpose of this trial?

The purpose of this study is to see if fecal microbiota transplantation (FMT) will prevent the future development of CDI. This is also known as fecal bacteriotherapy or stool transplant.

Research Team

YT

Ying Taur, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults (18+) who are scheduled to receive an allogeneic hematopoietic stem cell transplantation (allo-HSCT). It's not suitable for those with severe colitis, a history of inflammatory bowel disease, or those needing long-term antibiotics that affect the gut.

Inclusion Criteria

I am scheduled for a stem cell transplant from a donor.

Exclusion Criteria

I am on long-term antibiotics that affect my gut, as decided by my doctor.
I have severe bowel inflammation or a history of IBD.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-transplant Preparation

Feces are collected and stored from all participating subjects prior to the initiation of conditioning regimens, analyzed by deep 16S rRNA gene sequencing, and tested by assay for intestinal pathogens.

Varies

Treatment

Subjects undergo fecal microbiota transplantation with the subject's stored pre-transplantation feces within a 28-day window following engraftment.

28 days

Follow-up

Subjects are monitored for development of CDI, infections, and graft-versus-host disease. Fecal specimens are collected serially and analyzed for microbial diversity and composition.

1 year

Treatment Details

Interventions

  • Autologous Fecal Microbiota Transplantation (Auto-FMT)
Trial Overview The study is testing whether fecal microbiota transplantation (FMT) can prevent Clostridium Difficile Infection in patients after allo-HSCT. Some participants will get FMT while others won't and will just receive routine care.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Fecal microbiota transplantation with pre-transplant fecesExperimental Treatment1 Intervention
Prior to transplant hospitalization, store feces for testing and possible future use. Patients undergo fecal microbiota transplantation with the subject's stored pre-transplantation feces. The post-engraftment Bacteroidetes testing, randomization, and fecal microbiota transplantation procedure should all be performed within a 28-day window, beginning on the first day of engraftment. In the event that engraftment occurs prior to day +7, the 28-day window will start on day +7. Subjects from both arms will be followed for one year after transplantation for development of CDI, which will be treated by their BMT clinicians per the standards of care at MSKCC. Subjects from both arms will also be assessed for infections and graft-versus-host disease. During the follow-up period, fecal specimens will be collected serially, if feasible, until one year post randomization and analyzed for microbial diversity and composition.
Group II: No FMT, routine managementActive Control1 Intervention
Subjects from both arms will be followed for one year after randomization for development of CDI, which will be treated by their primary BMT clinician per the standards of care at MSKCC. Subjects from both arms will also be assessed by their BMT clinicians for infections and graft-versus-host disease. During the follow-up period, fecal specimens will be collected serially if feasible until one year post randomization and analyzed for microbial diversity and composition.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Findings from Research

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.
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) has shown a high success rate of 80-98% in treating severe and recurrent Clostridium difficile infections (CDI), particularly when administered via colonoscopy, which was the method used for most patients in the studies reviewed.
FMT works by restoring the normal microbiome of the colon, and evidence increasingly supports its effectiveness as a treatment option for CDI, although challenges such as patient perceptions and the need for standardized protocols remain.
Faecal microbiota transplantation for Clostridium difficile infection.Dodin, M., Katz, DE.[2020]
Fecal microbiota transplantation (FMT) using targeted colonic release capsules (FMTcr) showed a slightly higher clinical cure rate for recurrent Clostridium difficile infection (rCDI) at 80.6% compared to 75% for gastric release capsules (FMTgr), although the difference was not statistically significant.
Both FMT formulations were found to be safe with no serious adverse events, but FMTcr was more effective in increasing gut microbial diversity, suggesting better microbial engraftment patterns.
Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent Clostridium difficile Infection: A Comparative Cohort Analysis of High and Lose Dose.Allegretti, JR., Fischer, M., Sagi, SV., et al.[2020]

References

Safety and efficacy of fecal microbiota transplant in 9 critically ill patients with severe and complicated Clostridium difficile infection with impending colectomy. [2020]
Fecal Microbiota Transplant Decreases Mortality in Patients with Refractory Severe or Fulminant Clostridioides difficile Infection. [2021]
Faecal microbiota transplantation for Clostridium difficile infection. [2020]
Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent Clostridium difficile Infection: A Comparative Cohort Analysis of High and Lose Dose. [2020]
Physician attitudes toward the use of fecal microbiota transplantation for the treatment of recurrent Clostridium difficile infection. [2021]
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. [2021]
Case series of successful treatment with fecal microbiota transplant (FMT) oral capsules mixed from multiple donors even in patients previously treated with FMT enemas for recurrent Clostridium difficile infection. [2022]
Adverse events of fecal microbiota transplantation: a meta-analysis of high-quality studies. [2022]
Safety and tolerability of frozen, capsulized autologous faecal microbiota transplantation. A randomized double blinded phase I clinical trial. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Technical Aspects of Fecal Microbial Transplantation (FMT). [2018]
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