Stool Transplant to Control Treatment-related Diarrhea

  • STATUS
    Recruiting
  • End date
    May 23, 2023
  • participants needed
    10
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 23 May 2021

Summary

This study will test the safety, effectiveness, and feasibility of a treatment called fecal microbiota transplantation (FMT) to reduce the symptoms of ICI-related diarrhea.

Details
Condition Fecal Microbiota Transplantation
Treatment Fecal microbiota transplantation (FMT)
Clinical Study IdentifierNCT04883762
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on23 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years old
Patients treated with immune checkpoint inhibitors (ICI), including anti-CTLA-4, anti-PD-1 and anti-PDL-1 therapy for any malignant indication
Patients who develop diarrhea Grade 2 attributed to ICI, that persists despite treatment with corticosteroids for at least 72 hours and/or at least one dose of a biologic medication, such as infliximab or vedolizumab, with symptoms that persist or recur at least 72 hours post-infusion
Patients who develop diarrhea Grade 2 attributed to ICI and who have a contraindication to immunosuppressive treatment will also be eligible

Exclusion Criteria

Active GI infection, including untreated viral, bacterial or fungal or alternative identified cause(s) of diarrhea
Antibiotic exposure within 48 hours prior to FMT
Expected prolonged compromised immunity
Known HIV infection with CD4 count <240
ANC <1000/mm3 (use of growth factors to raise ANC is acceptable)
Seronegative for EBV or CMV (i.e. EBV IgG negative or CMV IgG negative)
Contraindications to anesthesia for procedure
Serious cardiopulmonary comorbidities
Inability to tolerate anesthesia
Pregnancy
Pregnant patients will be excluded from this study
Women of childbearing potential should not have plans to became pregnant or breastfeed an infant and must agree to use a highly effective method of birth control until 2 months after treatment with FMT (e.g. barrier method, oral or parenteral contraceptives, a vasectomized partner, or abstinence from sexual intercourse)
Severe food allergies
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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