What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common side effects of Fecal Microbiota Transplantation (FMT) include gastrointestinal symptoms such as diarrhea, cramping, bloating, and flatulence. There is also a risk of infection if the donor stool is not properly screened. Less common side effects may include fever and transient changes in bowel habits. Serious adverse events are rare but can include complications such as bowel perforation or transmission of infectious agents.

What prior FDA approvals exist?

Fecal Microbiota Transplantation (FMT) has been studied for its effectiveness in treating conditions like irritable bowel syndrome (IBS) and treatment-related diarrhea by replacing unhealthy bacteria with healthy bacteria from a donor. While specific FDA approvals for FMT are not detailed in the provided context, the treatment is generally recognized for its potential benefits in restoring healthy gut microbiota. FMT is typically administered via colonoscopy, enema, or oral capsules containing freeze-dried stool. The FDA has allowed the use of FMT under enforcement discretion for treating Clostridioides difficile infection not responsive to standard therapies, highlighting its growing acceptance in clinical practice.

What other types of research exist?

Promising alternatives to Fecal Microbiota Transplantation (FMT) for 2024 include the use of specific probiotics such as Lactobacillus reuteri DSM 17938, which has shown efficacy in treating conditions like infantile colic. Synbiotics, which combine probiotics and prebiotics, are also emerging as effective treatments, particularly for conditions like eczema and asthma. Additionally, advancements in the development of targeted microbiota therapies, including next-generation probiotics and microbiome-derived metabolites, are being explored for their potential to modulate gut health and treat various gastrointestinal disorders.

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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

No Placebo-Only Group

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.

Select...

I am 18 years old or older.

Select...

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:

Select...

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 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

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

Nausea

Bloody stools

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Fecal Microbiota Transplantation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~190

0 / 5Eligibility criteria met

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.