Fecal Microbiota Transplantation for Genitourinary Cancers

Recruiting in Palo Alto (17 mi)

Overseen by Yinghong Wang

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: M.D. Anderson Cancer Center

Must be taking: Immune checkpoint inhibitors

Must not be taking: Immunosuppressive treatments

Disqualifiers: Age < 18, Pregnancy, IBD, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Fecal microbiota transplantation may effectively reduce the incidence of immune checkpoint inhibitor-induced diarrhea/colitis.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop your current medications. However, if you have used steroids, you must have stopped them more than 30 days before the treatment, and if you have used immunosuppressants like Infliximab or Vedolizumab, you must have stopped them at least 3 months before the treatment.

What data supports the idea that Fecal Microbiota Transplantation for Genitourinary Cancers is an effective treatment?

The available research shows that Fecal Microbiota Transplantation (FMT) is primarily used for treating recurrent Clostridium difficile infections, and there is insufficient evidence to recommend it for other diseases, including genitourinary cancers. While FMT has been explored for various conditions like ulcerative colitis and metabolic syndrome, more research is needed to determine its effectiveness for cancer patients. Therefore, there is currently no strong data supporting FMT as an effective treatment for genitourinary cancers.

^{1 2 3 4 5}

What safety data exists for Fecal Microbiota Transplantation?

The safety of Fecal Microbiota Transplantation (FMT) has been evaluated in various studies, primarily focusing on its use for gastrointestinal conditions like ulcerative colitis. Systematic reviews and meta-analyses have assessed the safety of FMT, indicating it is generally considered safe for these conditions. Additionally, there is a case report of FMT being used in a kidney transplant recipient for recurrent urinary tract infections, suggesting its application beyond gastrointestinal issues. However, specific safety data for genitourinary cancers is not directly addressed in the provided research.

^{1 6 7 8 9}

Is Fecal Microbiota Transplantation a promising treatment for genitourinary cancers?

Fecal Microbiota Transplantation (FMT) is a promising treatment because it has shown potential in treating various diseases, including infections and possibly cancer. It works by introducing healthy bacteria into the body, which can help fight infections and improve health. Some studies suggest it might also help with urinary tract infections and cancer, making it a promising option for genitourinary cancers.

^{1 2 5 10 11}

Eligibility Criteria

This trial is for adults with genitourinary, melanoma, lung, ovarian, uterine, cervical or breast cancers who have diarrhea or colitis from immune-checkpoint inhibitors. They must not be pregnant/breastfeeding and should not have a high risk for colonoscopy complications or persistent GI infections.

Inclusion Criteria

I have been treated with immune checkpoint inhibitors.

I have had severe diarrhea or colitis from cancer treatment in the last 45 days.

Patient has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of protocol therapy

Exclusion Criteria

I started immunosuppressive treatment when my diarrhea or colitis began after cancer immunotherapy.

I experienced side effects not related to my digestive system during the study treatment.

I have active inflammatory bowel disease or radiation-induced bowel inflammation.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive loperamide orally and undergo fecal microbiota transplantation (FMT) via colonoscopy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Visits at 2, 4, and 8 weeks, and then at 3 months

Extension

Monitoring for recurrent immune-related diarrhea/colitis following FMT and immune checkpoint inhibitors (ICPI) resumption

Up to 6 months after restarting ICPI

Participant Groups

The study tests fecal microbiota transplantation (FMT) to treat immune-checkpoint inhibitor-induced diarrhea/colitis in cancer patients. It aims to see if FMT can reduce these side effects effectively compared to the standard treatment with Loperamide.

Group I: Treatment (loperamide, colonoscopy, FMT) Experimental Treatment 2 Interventions

Patients receive loperamide PO. After 4 hours, patients undergo FMT via colonoscopy over 15-30 minutes.

Fecal Microbiota Transplantation is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)

🇪🇺 Approved in European Union as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)
• Other gastrointestinal disorders

🇨🇦 Approved in Canada as Fecal Microbiota Transplantation for:

• Graft-versus-host disease (GVHD)
• Clostridioides difficile infection (CDI)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. Germany pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in a kidney transplant recipient with recurrent urinary tract infection. [2019] We report on a kidney transplant recipient treated with fecal microbiota transplantation (FMT) for recurrent urinary tract infections.

2. United States pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in patients with cancer undergoing treatment. [2020] Fecal microbiota transplantation (FMT) is a technique used to restore the normal body flora to the gut in cases of Clostridium difficile infection (CDI). It involves instillation of the stool of a healthy donor through a nasogastric tube or colonoscopy into the gastrointestinal tract of the patient. More research is needed to determine the parameters of FMT use in patients with cancer.

3. United States pubmed.ncbi.nlm.nih.gov

Low Level Engraftment and Improvement following a Single Colonoscopic Administration of Fecal Microbiota to Patients with Ulcerative Colitis. [2022] Fecal microbiota transplantation (FMT) is an investigational treatment for diseases thought to involve alterations in the intestinal microbiota including ulcerative colitis (UC). Case reports have described therapeutic benefit of FMT in patients with UC, possibly due to changes in the microbiota. We measured the degree to which the transplanted microbiota engraft following FMT in patients with UC using a donor similarity index (DSI).

4. United States pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation. [2020] Fecal microbiota transplantation (FMT) is the transfer of stool from a healthy donor into the colon of a patient whose disease is a result of an altered microbiome, with the goal of restoring the normal microbiota and thus curing the disease. The most effective and well-studied indication for FMT is recurrent Clostridium difficile infection. At this time, there is insufficient evidence to recommend FMT for other gastrointestinal diseases, but studies are under way. There is also insufficient evidence to recommend FMT for nongastrointestinal diseases at this time. The field is rapidly emerging.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in disease therapy. [2020] Fecal microbiota transplantation (FMT) is the introduction (transplantation) of gut microbiota obtained from the faeces of a healthy donor into the patient's gastrointestinal tract. Most often, such therapy is used the treatment of gastrointestinal diseases caused by the activity of pathogenic or conditionally pathogenic microorganisms, however, recently an increasing number of studies have reported the use of fecal microbiota transplantation for the treatment of diseases such as metabolic syndrome, diabetes, cancer and Parkinson's disease. This review article presents the results of studies concerning the impact of FMT on weight gain, immunological response and the treatment of neurological and gastrointestinal diseases and cancer. The procedure of fecal microbiota transplantation and possible side effects that may appear in FMT recipients are also described.

6. United States pubmed.ncbi.nlm.nih.gov

An updated systematic review and meta-analysis of fecal microbiota transplantation for the treatment of ulcerative colitis. [2023] Fecal microbiota transplantation (FMT) as a promising therapy for ulcerative colitis (UC) remains controversial. We conducted a systematic review and meta-analysis to assess the efficiency and safety of FMT as a treatment for UC.

7. United States pubmed.ncbi.nlm.nih.gov

Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. [2022] Several case series have reported the effects of fecal microbiota transplantation (FMT) for ulcerative colitis (UC). We assessed the efficacy and safety of FMT for patients with UC in a double-blind randomized trial.

8. United States pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. [2022] To study the clinical efficacy and safety of Fecal microbiota transplantation (FMT). We systematically reviewed FMT used as clinical therapy.

9. United States pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. [2022] Ulcerative colitis (UC) is difficult to treat, and standard therapy does not always induce remission. Fecal microbiota transplantation (FMT) is an alternative approach that induced remission in small series of patients with active UC. We investigated its safety and efficacy in a placebo-controlled randomized trial.

10. United States pubmed.ncbi.nlm.nih.gov

Intestinal microbiota and the efficacy of fecal microbiota transplantation in gastrointestinal disease. [2022] Fecal microbiota transplantation (FMT) refers to the infusion of a fecal suspension from a healthy person into the gastrointestinal (GI) tract of another person to cure a specific disease. FMT is by no means a new therapeutic modality, although it was only relatively recently that stool was shown to be a biologically active, complex mixture of living organisms with great therapeutic potential for recurrent Clostridium difficile infection and perhaps other GI and non-GI disorders. The published revelations about the human microbiome are bringing the strength of science to clinical observation and enhancing the understanding of not only disease but also how much of a person's daily function and health depends on the microorganisms living in intimate relationship with each cell in the body.

11. New Zealand pubmed.ncbi.nlm.nih.gov

Early Economic Assessment of Faecal Microbiota Transplantation for Patients with Urinary Tract Infections Caused by Multidrug-Resistant Organisms. [2023] The use of faecal microbiota transplantation (FMT) to eradicate intestinal carriage of multidrug-resistant organisms (MDRO) has been described in case reports and small case series. Although few in numbers, these patients suffer from recurrent infections that may exacerbate both the patients' comorbidities and their healths. In the current study, we hypothesized that FMT for MDRO-related urinary tract infections (UTIs) reduces hospitalisations and associated costs.