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Stool Transplant Safety for C. difficile Infection
N/A
Waitlist Available
Led By Robin B. Mendelsohn, MD
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
Clinical and microbiologic relapse of C. difficile associated diarrhea after at least one course of adequate antibiotic therapy or refractory disease that does not respond to treatment
≥18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks after the fmt
Awards & highlights
Study Summary
This trial will test if FMT is safe for patients with cancer and C. difficile. Previous studies have shown that it can cure C. difficile when antibiotics have failed, but most of these studies have not included patients with cancer.
Who is the study for?
This trial is for adults over 18 with solid organ cancer who've had chemotherapy in the last six months and are struggling with a tough C. difficile infection despite antibiotics. They should have a life expectancy of more than three months but can't join if they have blood cancers, certain GI conditions, severe immune deficiencies, or are pregnant.Check my eligibility
What is being tested?
The study is examining the safety of Fecal Microbiota Transplantation (FMT) in patients who have both cancer and difficult-to-treat C. difficile infections to see if it's safe enough for doctors to recommend widely.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort at the transplant site, bloating, changes in bowel habits, and risks associated with anesthesia used during the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My C. difficile infection came back after treatment or didn't respond to it.
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I am 18 years old or older.
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I have taken vancomycin or metronidazole for at least 10 days.
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I have had frequent diarrhea and tested positive for C. difficile.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks after the fmt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks after the fmt
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate safety based the number of infections
Side effects data
From 2016 Phase 1 trial • 23 Patients • NCT0210882148%
Abdominal Pain
22%
Flatulence and bloating
22%
Diarrhea
13%
Emesis
9%
Bloody stools
9%
Nausea
4%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fecal Microbiota Transplantation
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota Transplantation (FMT)Experimental Treatment1 Intervention
Patients with recurrent or refractory CDI who meet study eligibility criteria, will consent to undergo either colonoscopy or upper endoscopy with infusion of stool admixture. Safety will be assessed by monitoring infections that occurred within 2 weeks of the FMT procedures. Additionally, 24-hours, 1 week, 2 weeks, 4 weeks, and 6 months post-FMT, a stool sample will be collected. The time window for each time point listed is +/- 48 hours, with the exception of the first, 24 hour, time point. The time window for the 24 hour time point is +48 hours post FMT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation (FMT)
2016
Completed Phase 1
~170
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,927 Previous Clinical Trials
591,397 Total Patients Enrolled
Robin B. Mendelsohn, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stem cell transplant.My C. difficile infection came back after treatment or didn't respond to it.I have not had any gastrointestinal surgery in the last 3 months.I have had chemotherapy for cancer in the last 6 months.I have a blockage in my intestine.I have been diagnosed with gastroparesis.I am at risk of bleeding during procedures.I am 18 years old or older.I do not have any stomach or intestine problems that prevent me from taking certain medications.I have been diagnosed with inflammatory bowel disease.I have an active fistula.I have a blood cancer.I have a blockage in my small intestine.I have taken vancomycin or metronidazole for at least 10 days.I have had frequent diarrhea and tested positive for C. difficile.I cannot have anesthesia due to health reasons.I have serious heart or lung health issues.I am HIV positive with a CD4 count below 240.I experience nausea and vomiting.
Research Study Groups:
This trial has the following groups:- Group 1: Fecal Microbiota Transplantation (FMT)
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.
Does the research team need additional participants for this experiment?
"Data hosted on clinicaltrials.gov implies that this particular medical study is no longer actively recruiting individuals, as it was last updated in October 26th 2022. Nonetheless, 1253 other trials are open to participants at the moment."
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