Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04038619
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fecal Microbiota Transplantation — PROCEDURE
    Undergo FMT via colonoscopy
  • Loperamide — DRUG
    Given PO

Study Details

This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Fecal microbiota transplantation may effectively reduce the incidence of immune checkpoint inhibitor-induced diarrhea/colitis.

Key Dates

Start date
Feb 1, 2021
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (loperamide, colonoscopy, FMT)
    Patients receive loperamide PO. After 4 hours, patients undergo FMT via colonoscopy over 15-30 minutes.

Primary Outcome Measure

Incidence of fecal microbiota transplantation (FMT)-related adverse events [ Time Frame: Up to 3 months post-FMT ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Yinghong Wang
713-792-7672
Yinghong Wang (PRINCIPAL_INVESTIGATOR)

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OncologyBreast oncologyWomen's healthGynecologic oncologyLung oncologyLung diseaseSkin cancerDermatology
By research site
M D Anderson Cancer Center· Houston, TX

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