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

Launched by STATE UNIVERSITY OF NEW YORK - UPSTATE MEDICAL UNIVERSITY · Nov 20, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring whether taking probiotics can help kidney transplant patients who are experiencing diarrhea caused by their immunosuppressive medications. Immunosuppressive drugs are important because they help prevent the body from rejecting the new kidney, but they can also lead to gastrointestinal issues like diarrhea. The study aims to see if probiotics can reduce this diarrhea and inflammation, while also looking into how this treatment affects gut bacteria and immune responses in patients.

To be eligible for the trial, participants must be kidney transplant recipients from either living or deceased donors and have mild to severe diarrhea that occurs more than three times a day. They should also be taking certain immunosuppressive medications. However, pregnant or breastfeeding women, those with certain gastrointestinal conditions, or anyone currently using probiotics will not be able to participate. Participants will take either a probiotics capsule or a placebo (a non-active capsule) once daily for six months. The researchers will compare the results from both groups to see if the probiotics have any positive effects. This study is important as it could potentially improve the quality of life for kidney transplant patients dealing with medication-related diarrhea.

Gender

ALL

Eligibility 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 \[(positive for toxin A and B) and enteropathogenic E. coli (positive Shiga toxins)\].