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1

Fecal Microbiota Transplantation for Immunotherapy-Related Diarrhea 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 diarrhea and colitis.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who developed diarrhea 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 <span class="highlight">microbiome)</span> 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 diarrhea.</li> <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 <span class="highlight">microbiome.</li></span> <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 Diarrhea 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 from 94108:
1644 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

2

How the Gut <span class="highlight">Microbiome</span> May Affect Immunotherapy in Stage I-IV Triple Negative Breast Cancer

The Gut <span class="highlight">Microbiome</span> and Immune Checkpoint Inhibitor Therapy in Solid Tumors

Purpose: To study the gut <span class="highlight">microbiome</span> to see if it can determine if immunotherapy will be effective.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) triple negative breast cancer (ER-, PR- and HER2-) who are about to begin treatment with a checkpoint inhibitor (immunotherapy). You must speak English or Spanish. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 blood tests over 6-8 weeks</li> <li class="seamTextUnorderedListItem">2 stool samples over 6-8 weeks</li> <li class="seamTextUnorderedListItem">Questionairres (in English or Spanish)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The <span class="highlight">microbiome</span> may help determine if immunotherapy will be effective. </li> <li class="seamTextUnorderedListItem">By studying the <span class="highlight">microbiome,</span> researchers may also be able to determine if changing the <span class="highlight">microbiome</span> through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, can help the immune system fight cancer.</li> <li class="seamTextUnorderedListItem">Immunotherapies are drugs that trigger the immune system to see, go after, and kill cancer cells. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) and atezolizumab (Tecentriq®) are a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</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/NCT05037825' target='_blank'>ClinicalTrials.gov</a> </li></ul>
2

How the Gut <span class="highlight">Microbiome</span> May Affect Immunotherapy in Stage I-IV Triple Negative Breast Cancer

The Gut <span class="highlight">Microbiome</span> and Immune Checkpoint Inhibitor Therapy in Solid Tumors
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Nearest Location from 94108:
1986 miles
Baptist Health Clinical Research
Elizabethtown, KY

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Visits:
At least 2 visits over 6-8 weeks

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ClinicalTrials.gov: NCT05037825

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Phase NA

3

Probiotic Supplement for Women With Breast Cancer

A Randomized, Double-blind, Placebo Controlled, Parallel Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer Patients

Purpose: To study how well a probiotic can change the mix of microorganisms (like bacteria and fungi) in the gut <span class="highlight">microbiome</span> and breast tissue in people with breast cancer.

Who is this for?: Women with stage I or stage II or stage III or stage IV (invasive ductal carcinoma [IDC] or invasive lobular carcinoma [ILC]) breast cancer. You must agree to avoid unpasteurized fermented foods and probiotics and to keep your usual diet and activity level before the study starts and while you are in the study. View full eligibility criteria

What's involved?


What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The gut <span class="highlight">microbiome</span> is made up of bacteria, viruses, and other organisms that live in the digestive tract and help keep us healthy.</li> <li class="seamTextUnorderedListItem">A probiotic, called BIOHM, is a food supplement that is believed to balance bacteria and fungi in the body.</li> <li class="seamTextUnorderedListItem">This study is looking at whether taking BIOHM may help change the body’s <span class="highlight">microbiome</span> in people with breast 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/NCT04362826' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/diet-nutrition/dietary-supplements/known/probiotics' target='_blank'>Breastcancer.org: Probiotics and Breast Cancer</a> </li></ul>
3

Probiotic Supplement for Women With Breast Cancer

A Randomized, Double-blind, Placebo Controlled, Parallel Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer Patients
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Nearest Location from 94108:
2172 miles
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, OH

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Visits:
At least 2 visits in 6 weeks

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ClinicalTrials.gov: NCT04362826

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Phase NA

4

Registry to Study the Impact of the Gut <span class="highlight">Microbiome</span> on Brain Tumors

Study of Human Brain-Gut Axis and Gut <span class="highlight">Microbiome</span> In Patients With Brain Lesions - Repository for Neuroscience Research

Purpose: To study the impact of the gut <span class="highlight">microbiome</span> on the growth and progression of brain tumors.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive surgery. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood, tissue, saliva, urine and stool samples</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stool samples will be used to study your gut <span class="highlight">microbiome,</span> which are the microorganisms that live in your digestive system.</li> <li class="seamTextUnorderedListItem">The harmful bacteria cause disease such as infection, and the beneficial bacteria help keep you healthy.</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/NCT06117930' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
4

Registry to Study the Impact of the Gut <span class="highlight">Microbiome</span> on Brain Tumors

Study of Human Brain-Gut Axis and Gut <span class="highlight">Microbiome</span> In Patients With Brain Lesions - Repository for Neuroscience Research
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Nearest Location from 94108:
2383 miles
Mayo Clinic in Florida
Jacksonville, FL

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Visits:
Coincides with surgery and routine care

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ClinicalTrials.gov: NCT06117930

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Phase NA

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