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Fecal Microbiota Transplantation
Fecal Microbiota Transplant for Clostridium Infections
Phase 2
Waitlist Available
Led By Ying Taur, MD, MPH
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Planned to undergo allo-HSCT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year following randomization
Awards & highlights
Study Summary
This trial is testing whether fecal microbiota transplantation (FMT) can prevent the future development of Clostridium difficile infection (CDI).
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from FMT may include discomfort at the administration site, bloating, diarrhea, nausea or infection. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am scheduled for a stem cell transplant from a donor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year following randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year following randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clostridium difficile infection (CDI)
Trial Design
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.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,145 Total Patients Enrolled
Ying Taur, MD, MPHPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on long-term antibiotics that affect my gut, as decided by my doctor.I am 18 years old or older.I have severe bowel inflammation or a history of IBD.I am scheduled for a stem cell transplant from a donor.
Research Study Groups:
This trial has the following groups:- Group 1: Fecal microbiota transplantation with pre-transplant feces
- Group 2: No FMT, routine management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this a controlled trial or are there still places open for volunteers?
"The latest information from clinicaltrials.gov reveals that this study is no longer looking for patients. The trial was initially posted on October 1st, 2014 and had its last update on July 25th, 2022. Although this study has completed recruitment, there are 41 other active trials that are currently looking for participants."
Answered by AI
Has the FDA sanctioned fecal microbiota transplantation (FMT)?
"Fecal microbiota transplantation (FMT) is a medical procedure that has shown some efficacy in clinical trials but is not yet approved by the FDA. Our team rates its safety at a 2."
Answered by AI
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