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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
Must not have
Contraindications to anesthesia for procedure indicated by at least one of the below: Serious cardiopulmonary comorbidities, Inability to tolerate anesthesia
Active GI infection, including untreated viral, bacterial or fungal or alternative identified cause(s) of diarrhea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for 7 days after each fmt
Awards & highlights

Summary

This trial is testing a treatment called fecal microbiota transplantation (FMT) to help patients with diarrhea caused by cancer treatments. FMT involves transferring stool from a healthy person into the intestines of a sick person. The healthy bacteria in the donor's stool are expected to replace the unhealthy bacteria in the recipient's gut, improving their symptoms. FMT has been proven to be a safe and effective treatment for Clostridium difficile infection (CDI) and it is now a recommended treatment for recurrent or refractory infection.

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.
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.
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 below
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I have experienced severe diarrhea due to immune checkpoint inhibitor therapy.
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I am 18 years old or older.
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I have been treated with immune therapy for cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot undergo anesthesia due to serious heart/lung issues or intolerance.
Select...
I do not have an active infection in my digestive system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for 7 days after each fmt
This trial's timeline: 3 weeks for screening, Varies for treatment, and for 7 days after each fmt for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of fecal microbiota transplantation (FMT)-related adverse events

Side effects data

From 2016 Phase 1 trial • 23 Patients • NCT02108821
48%
Abdominal Pain
22%
Diarrhea
22%
Flatulence and bloating
13%
Emesis
9%
Nausea
9%
Bloody stools
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Fecal Microbiota Transplant (FMT) works by introducing healthy bacteria from a donor's stool into the recipient's intestine, aiming to restore a balanced gut microbiome. This is particularly important for patients with conditions like antibiotic-associated diarrhea or irritable bowel syndrome, where the gut microbiota is disrupted. The healthy bacteria can outcompete harmful bacteria, reduce inflammation, and improve gut function, leading to symptom relief and improved intestinal health. This mechanism is crucial as it addresses the root cause of dysbiosis, offering a potential long-term solution rather than just symptomatic relief.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,960 Previous Clinical Trials
596,723 Total Patients Enrolled
David Faleck, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Fecal Microbiota Transplantation (FMT) (Microbiota Restoration) Clinical Trial Eligibility Overview. Trial Name: NCT04883762 — Phase 1
Fecal Microbiota Transplant (FMT) Research Study Groups: Fecal Microbiota Transplantation (FMT)
Fecal Microbiota Transplant (FMT) Clinical Trial 2023: Fecal Microbiota Transplantation (FMT) Highlights & Side Effects. Trial Name: NCT04883762 — Phase 1
Fecal Microbiota Transplantation (FMT) (Microbiota Restoration) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04883762 — Phase 1
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