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

Early Phase 1

Not yet recruiting

• Conditions: Renal Transplantation
• Interventions: Other: Florajen Digestion

• Registration Number: NCT06150287
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-29
• Status Verified: 2023-12
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Study Start: 2024-12
• Primary Completion: 2026-12
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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)].

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics Group	Florajen Digestion	Participants will receive one probiotics capsule daily for six months immediately after the onset of post-surgical non-infectious diarrhea.
Placebo Group	Florajen Digestion	Participants will receive one placebo capsule daily for six months immediately after the onset of post-surgical non-infectious diarrhea.

Primary Outcome Measures

Name	Time	Method
Analysis of inflammatory biomarkers	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	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).
Reduction in immunosuppressive drugs-associated diarrhea	GI questionnaire and Bristol Stool Chart will be collected daily for six months from the onset of post-surgical, non-infectious diarrhea.	Gastrointestinal (GI) questionnaire and Bristol Stool Chart will be used to measure this outcome through Chi-Square test.
Association between inflammatory markers and fecal microbiome	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.	Fecal microbial DNA will be analyzed through 16S PCR followed by Next-Gen sequencing. Pearson correlation analysis will be performed.