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1

Fecal Microbiota Transplantation for Immunotherapy-Related <span class="highlight">Diarrhea</span> or Colitis in People with Stage I-IV Breast Cancer

Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea/Colitis in Genitourinary Cancer Patients

Purpose: To study the ability of a fecal microbiota transplantation to improve immune checkpoint inhibitor-related <span class="highlight">diarrhea</span> and colitis.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who developed <span class="highlight">diarrhea</span> and/or colitis after receiving treatment with dostarlimab (Jemperli®) or pembrolizumab (Keytruda®) immune checkpoint inhibitors. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Loperamide, by mouth, 1 time</li> </ul> <p class="seamTextPara"> followed 4 hours later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fecal microbiota transplantation during colonoscopy, 1 time</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A fecal microbiota transplantation consists of taking healthy bacteria (microbiota or microbiome) from the feces or stool of a healthy donor and transferring them to the colon of the recipient during a colonoscopy.</li> <li class="seamTextUnorderedListItem">A colonoscopy is a procedure in which a flexible camera is inserted through the anus to examine the colon/intestines.</li> <li class="seamTextUnorderedListItem">Loperamide is a drug used to treat <span class="highlight">diarrhea.</li></span> <li class="seamTextUnorderedListItem">Colitis is inflammation of the colon/intestines.</li> <li class="seamTextUnorderedListItem">Your body is home to many bacteria, viruses, and fungi, which are collectively called the microbiome.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04038619' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2018-0663.html' target='_blank'>MD Anderson Cancer Center: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/fecal-transplant' target='_blank'>Johns Hopkins Medicine: Fecal Microbiota Transplantation</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a682280.html' target='_blank'>MedlinePlus: Loperamide</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immune Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>
1

Fecal Microbiota Transplantation for Immunotherapy-Related <span class="highlight">Diarrhea</span> or Colitis in People with Stage I-IV Breast Cancer

Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea/Colitis in Genitourinary Cancer Patients
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Nearest Location:
1643 miles
M D Anderson Cancer Center
Houston, TX

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Visits:
5 visits within 3 months

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ClinicalTrials.gov: NCT04038619

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Phase I

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