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Microbiota Therapy

Fecal Microbiota Transplantation for Genitourinary Cancers

Phase 1

Recruiting

Led By Yinghong Wang

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treatment with any ICPI agent(s)

Patients with new onset of ≥ grade 2 ICPI-induced diarrhea and/or colitis symptoms based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5 within 45 days prior to date of FMT treatment without involvement of non- GI toxicity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months after restarting icpi

Awards & highlights

Study Summary

This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis caused by certain medications. Fecal microbiota transplantation may reduce the incidence of these conditions.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects of FMT may include temporary digestive discomfort like bloating and gas. There's also a small risk of infection transmission through the transplanted material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated with immune checkpoint inhibitors.

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

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I have been diagnosed with cancer in my reproductive organs, skin, lungs, or breasts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months after restarting icpi

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months after restarting icpi

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after restarting icpi for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical response/remission of immune-related diarrhea/colitis

Incidence of fecal microbiota transplantation (FMT)-related adverse events

Secondary outcome measures

Recurrent immune-related diarrhea/colitis within 3 months post-FMT after initially achieving clinical remission/response

Other outcome measures

Endoscopic remission (Mayo Clinic sub-score 0-1) of immune-related diarrhea/colitis

Frequencies of immune cells (CD4/8 T cells, regulatory T cells [Treg], macrophages, etc.) in tissue/blood/stool samples

Histological remission (resolution of active inflammation) of immune-related diarrhea/colitis

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (loperamide, colonoscopy, FMT)Experimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Loperamide

FDA approved

Fecal Microbiota Transplantation

2016

Completed Phase 2

~350

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,306 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,666 Previous Clinical Trials

40,925,965 Total Patients Enrolled

Yinghong WangPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

900 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been recruited to participate in this investigation?

"Affirmative. The details on clinicaltrials.gov affirm that this study is actively looking for participants and began recruitment on February 1st 2021. At the moment, 40 volunteers are needed to be recruited from one medical centre before October 17th 2022."

Answered by AI

Are there any unoccupied positions in this clinical investigation?

"The research team is currently looking for eligible participants. The initial posting of the trial was on February 1st, 2021 and it has been amended as recently as October 17th, 2022 according to clinicaltrials.gov."

Answered by AI

What condition is typically remedied through loperamide, colonoscopy and FMT?

"Treatment (loperamide, colonoscopy, FMT) is typically used in order to manage inflammatory bowel diseases (IBD), looseness of the bowels and chronic functional diarrhea."

Answered by AI

Does this medical experiment introduce any groundbreaking concepts?

"Currently, there are 9 ongoing clinical trials examining the efficacy of Treatment (loperamide, colonoscopy, FMT) in 63 cities and 19 countries. The first such study was conducted by Eli Lilly and Company back in 2014 with 198 participants taking part. Since then, an additional 39 studies have been launched."

Answered by AI

Has the FDA sanctioned loperamide, colonoscopy, or FMT as a therapeutic measure?

"Our experts at Power have evaluated the safety of this treatment plan (loperamide, colonoscopy and FMT) to be a 1 as it is in its initial phase of testing. Efficacy data is still sparse while any evidence supporting safety has been limited."

Answered by AI

What research has been conducted to assess the efficacy of loperamide, colonoscopy and FMT for treating patients?

"Currently, 9 experiments surrounding Treatment (loperamide, colonoscopy, FMT) are underway with 1 trial in Phase 3. Nagoya-shi, Aichi is the primary location of these Trails while 156 sites are participating in clinical trials related to Treatment (loperamide, colonoscopy, FMT)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients

2021. "Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04038619.

All > Inflammatory Bowel Disease > Colitis