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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
Must not have
Immunosuppressive treatment at onset of ICPI-induced diarrhea/colitis
Patients who develop concurrent non-GI toxicity at the time of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after restarting icpi
Awards & highlights
No Placebo-Only Group
Approved for 10 Other Conditions
All Individual Drugs Already Approved
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I started immunosuppressive treatment when my diarrhea or colitis began after cancer immunotherapy.
Select...
I experienced side effects not related to my digestive system during the study treatment.
Select...
I have active inflammatory bowel disease or radiation-induced bowel inflammation.
Select...
I have a GI infection that didn't clear after 5 days of antibiotics.
Select...
I am under 18 years old.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical response/remission of immune-related diarrhea/colitis
Incidence of fecal microbiota transplantation (FMT)-related adverse events
Secondary study objectives
Recurrent immune-related diarrhea/colitis within 3 months post-FMT after initially achieving clinical remission/response
Other study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
2020
Completed Phase 2
~440
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,286 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,043 Total Patients Enrolled
Yinghong WangPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
900 Total Patients Enrolled