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NOT YET RECRUITING
NCT06150287
EARLY_PHASE1

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

Sponsor: State University of New York - Upstate Medical University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2024-12

Completion Date

2027-05

Last Updated

2024-05-13

Healthy Volunteers

No

Interventions

OTHER

Florajen Digestion

Florajen Digestion is a probiotics. One probiotics capsule contains 15 billion Colony Forming Unit (CFU) of live microorganisms. No live microorganisms are present in the placebo capsules.