Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients Wi… (NCT03819296) | Clinical Trial Compass
RecruitingPhase 1
Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
United States800 participantsStarted 2021-02-21
Plain-language summary
This trial studies the role of the gut microbiome and effectiveness of a fecal transplant on medication-induced gastrointestinal (GI) complications in patients with melanoma or genitourinary cancer. The gut microbiome (the bacteria and microorganisms that live in the digestive system) may affect whether or not someone develops colitis (inflammation of the intestines) during cancer treatment with immune-checkpoint inhibitor drugs. Studying samples of stool, blood, and tissue from patients with melanoma or genitourinary cancer may help doctors learn more about the effects of treatment on cells, and help doctors understand how well patients respond to treatment. Treatment with fecal transplantation may help to improve diarrhea and colitis symptoms.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1).
✓. Diagnosis of any cancer type (Projects 2 and 3)
✓. Treatment with any ICPI agent
✓. Ability to understand and willingness to sign an informed consent form and rate surveys
✓. Life expectancy \> 4 months (Project 3)
✓. ICPI-related diarrhea and/or colitis of any grade with or without concurrent non- GI toxicity as the toxicity group (project 1)
✓. Patients with no organ toxicity as the control group (project 1)
✓. ICPI-related colitis and/or diarrhea of grade ≥ 2 as GI toxicity (initial episode or recurrence) receiving standard treatment of immunosuppressive agents (steroid, infliximab, vedolizumab, or ustekinumab) any time during the colitis disease course until sustained resolution of GI toxicity, or one- year time point after enrollment (Project 2)
Exclusion criteria
What they're measuring
1
Difference in stool microbiome pattern
Timeframe: Up to 1 year
2
Incidence of adverse events (AE) of fecal microbiota transplantation (FMT) (Project 3)
✕. History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation
✕. Pregnant and breastfeeding women
✕. Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \> 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment
✕. Patients who develop concurrent non- GI toxicity at the time of FMT treatment (project 3)
✕. Patients with active bacterial or fungal infection (Project 3)
✕. Donors at risk for monkeypox infection and/ or exposure as determined by a questionnaire (Project 3)
✕. Patients may withdraw from the trial at any time