Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06150287 | NOT YET RECRUITING | Renal Transplantation

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

State University of New York - Upstate Medical University

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 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.

Condition or disease

Renal Transplantation

Intervention/treatment

Florajen Digestion

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : QUADRUPLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Effect of Probiotics on Immunosuppressive-drug-associated Diarrhea Among Renal Transplant Recipients
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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 Criteria
  • * 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 \[(positive for toxin A and B) and enteropathogenic E. coli (positive Shiga toxins)\].
Effect of Probiotics on Immunosuppressive-drug-associated Diarrhea Among Renal Transplant Recipients

Location Details

NCT06150287

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found