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.
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.
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
Parallel
Florajen Digestion
Other interventionFlorajen 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.
Reduction in immunosuppressive drugs-associated diarrhea
Gastrointestinal (GI) questionnaire and Bristol Stool Chart will be used to measure this outcome through Chi-Square test.
Analysis of inflammatory biomarkers
Inflammatory biomarkers including TNF (tumor necrosis factor) superfamily proteins, IFN (interferon) family proteins, Treg cytokines and matrix metalloproteinases (MMP) \[processed through Bio-Rad's Multiplex System) will be analyzed through general linear model analysis of variance (GLM ANOVA).
Association between inflammatory markers and fecal microbiome
Fecal microbial DNA will be analyzed through 16S PCR followed by Next-Gen sequencing. Pearson correlation analysis will be performed.
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