Effect of Probiotics on Immunosuppressive-drug-associated Diarrhea Among Renal Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Florajen Digestion.
- Who it may be relevant to
- Registry conditions: Renal Transplantation. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Reduction in immunosuppressive drugs-associated diarrhea [Time frame: GI questionnaire and Bristol Stool Chart will be collected daily for six months from the onset of post-surgical, non-infectious diarrhea.]
- Analysis of inflammatory biomarkers [Time frame: Whole blood will be collected three times for six months: baseline (on the day of transplant), 3 month and six month from the onset of post-surgical, non-infectious diarrhea. three and six months]
- Association between inflammatory markers and fecal microbiome [Time frame: Stool samples will be collected seven times for six months: baseline (on the day of transplant), then monthly once from the onset of post-surgical, non-infectious diarrhea.]
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 \[(positive for toxin A and B) and enteropathogenic E. coli (positive Shiga toxins)\].
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Roy M, Podolak T, Pankewycz O and Leftavi MR. Effect of Probiotics on Immunosuppressive Drugs Associated Diarrhea in Renal Transplant Recipients: A Practice-Based Observation. Renal Journal of Nutrition. 2018; 28:141.
Identifiers
NCT: NCT06150287 · 2044457