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Microbiota Restoration
Stool Transplant for Immunotherapy-Related Diarrhea
Phase 1
Waitlist Available
Led By David Faleck, 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
Patient has developed diarrhea ≥ Grade 2 attributed to ICI
≥ 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for 7 days after each fmt
Awards & highlights
Study Summary
This trial will test a potential treatment for diarrhea caused by immunotherapy drugs. The treatment, called fecal microbiota transplantation, involves transplanting feces from a healthy donor into the patient.
Who is the study for?
This trial is for adults over 18 who have been treated with immune checkpoint inhibitors for cancer and are experiencing persistent diarrhea (Grade 2 or higher) despite treatment. It's not suitable for those with serious heart/lung issues, an inability to handle anesthesia, pregnant women, or those planning pregnancy/breastfeeding soon.Check my eligibility
What is being tested?
The study is examining fecal microbiota transplantation (FMT), where stool from a healthy donor is infused into the patient's intestines via colonoscopy. The goal is to restore healthy bacteria balance and alleviate ICI-related diarrhea.See study design
What are the potential side effects?
Potential side effects may include discomfort from the colonoscopy procedure, risks associated with anesthesia, and possible infection if unhealthy bacteria are transmitted during FMT.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have experienced severe diarrhea due to immune checkpoint inhibitor therapy.
Select...
I am 18 years old or older.
Select...
I have been treated with immune therapy for cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for 7 days after each fmt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for 7 days after each fmt
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of fecal microbiota transplantation (FMT)-related adverse events
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
Study subjects will undergo standard bowel preparation and diagnostic colonoscopy with routine biopsies for pathologic assessment. FMT will be performed at the proximal extent of the colon reached, according to the same protocol used in prior randomized studies. FMT will use healthy donor stool provided by OpenBiome, a nonprofit 501(c)(3) organization that provides clinicians and hospitals with screened, filtered and frozen stool to be used for FMT. Routine clinical and research biopsies will be collected during the FMT colonoscopy procedure.
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
1,937 Previous Clinical Trials
588,316 Total Patients Enrolled
David Faleck, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot undergo anesthesia due to serious heart/lung issues or intolerance.I do not have an active infection in my digestive system.I have severe diarrhea from cancer treatment that didn't improve with specific medications.I have experienced severe diarrhea due to immune checkpoint inhibitor therapy.You have serious allergies to certain types of food.I am 18 years old or older.I have not taken antibiotics within the last 48 hours.I have been treated with immune therapy for cancer.
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.
Has the FDA sanctioned Fecal Microbiota Transplantation (FMT) for therapeutic use?
"Limited data is available when examining Fecal Microbiota Transplantation's efficacy and safety, earning it a score of 1 on our scale."
Answered by AI
Are there any vacancies available for participants of this medical experiment?
"Affirmative. Clinicaltrials.gov states that this medical trial is expansive, having been posted on May 10th 2021 and updated as recently November 7th 2022. As of now, the research team seeks to recruit a total of 10 individuals from one location."
Answered by AI
What is the maximum number of participants allowed in this experiment?
"Indeed, clinicaltrials.gov lists this trial as presently looking for subjects. The initial posting of the study was on May 10th 2021 and it has been recently updated November 7th 2022. Currently there is need to recruit 10 people at a single medical centre."
Answered by AI
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