Status:
NOT_YET_RECRUITING
Effect of Probiotics on Immunosuppressive-drug-associated Diarrhea Among Renal Transplant Recipients
Lead Sponsor:
State University of New York - Upstate Medical University
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief 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 immun...
Eligibility Criteria
Inclusion
- Received living or deceased donor kidney, subjects will be monitored peri-operatively
- Presence of mild to severe diarrhea (\> 3 times loose stools/day); include type 6 and 7 in the Bristol Stool Chart.
- Has been on adjusted and/or maintenance dose of calcineurin inhibitors, antimetabolites and steroid regimen. Treatment of rejection including administration of steroids, intravenous immunoglobulin/plasmapheresis, rituximab and anti- thymocytes are also acceptable in this research.
Exclusion
- Pregnant and lactating women
- Has been receiving probiotics treatment
- Recurrence of gastrointestinal diseases including inflammatory bowel diseases, diverticulosis, irritable bowel syndrome. Had past surgical history of gastric bypass.
- Diagnosed with cancer
- Presence of infectious diarrhea, fever and high white blood cells (WBC) count. Infectious diarrhea is defined by polymerase chain reaction (PCR) negative for community acquired diarrhea panel \[positive for Sapo virus, Noro virus, Clostridium difficile (positive for toxin A and B), Yersinia enterocolitica \[(positive for toxin A and B) and enteropathogenic E. coli (positive Shiga toxins)\].
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06150287
Start Date
December 1 2024
End Date
May 1 2027
Last Update
May 13 2024
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