Clinical trial NCT06150287: Effect of Probiotics on Immunosuppressive-drug-associated Diarrhea Among Renal Transplant Recipients
Official title: Effect of Probiotics on Immunosuppressive-drug-associated Diarrhea Among Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Renal Transplantation
Keywords: Probiotics
Immunosuppressive Drugs
Renal Transplantation
Diarrhea
Living Donor
Deceased Donor
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blinded, placebo-controlled, single-center pilot/exploratory trial
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Reduction in immunosuppressive drugs-associated diarrhea
timeFrame: GI questionnaire and Bristol Stool Chart will be collected daily for six months from the onset of post-surgical, non-infectious diarrhea.
measure: Analysis of inflammatory biomarkers
timeFrame: 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
measure: Association between inflammatory markers and fecal microbiome
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Reza Saidi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.