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Effect of Probiotics on Immunosuppressive-drug-associated Diarrhea Among Renal Transplant Recipients

StatusNot Yet Recruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Notable Start date: Apr 2024 to Dec 2024v4
  2. Notable Start date: Feb 2024 to Apr 2024v3
  3. Notable Primary completion date: May 2025 to Dec 2026
    • Study completion date: Dec 2025 to May 2027
    • Start date: Jan 2024 to Feb 2024
    • Eligibility criteria expanded, about 8 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this pilot project is to 1) examine whether oral administration of probiotics are helpful in reducing immunosuppressive drugs-associated diarrhea and adhering to the required dose of immunosuppressive drugs and 2) determine how this treatment works by examining fecal microbiome and immunological markers among living and deceased donor renal transplant recipients. The main questions it aims to answer are: 1. Does low dose probiotics effective in reducing immunosuppressive drugs-associated diarrhea? 2. Does probiotics effective in reducing inflammation? 3. Is there any connection between fecal microbiome and immunological markers? Participants will receive one probiotics capsule or placebo capsule daily for 6 months from the onset of diarrhea post-surgically. Researchers will compare the data obtained through probiotics group and placebo group to answer the above mentioned research questions.
Trial Details
NCT Number NCT06150287
Lead Sponsor State University of New York - Upstate Medical University
Conditions
(from sponsor)
Renal Transplantation
Related terms Diarrhea
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov