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

NCT06150287 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 2044457
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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. 1.Does low dose probiotics effective in reducing immunosuppressive drugs-associated diarrhea?
2. 2.Does probiotics effective in reducing inflammation?
3. 3.Is there any connection between fecal microbiome and immunological markers?

Conditions

Renal Transplantation

Keywords

Probiotics; Immunosuppressive Drugs; Renal Transplantation; Diarrhea; Living Donor; Deceased Donor

Outcome Measures

Primary Outcomes (3)

• Reduction in immunosuppressive drugs-associated diarrhea

  Gastrointestinal (GI) questionnaire and Bristol Stool Chart will be used to measure this outcome through Chi-Square test.

  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

  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).

  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

  Fecal microbial DNA will be analyzed through 16S PCR followed by Next-Gen sequencing. Pearson correlation analysis will be performed.

  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.

Study Arms (2)

Probiotics Group

ACTIVE COMPARATOR

Participants will receive one probiotics capsule daily for six months immediately after the onset of post-surgical non-infectious diarrhea.

Other: Florajen Digestion

Placebo Group

PLACEBO COMPARATOR

Participants will receive one placebo capsule daily for six months immediately after the onset of post-surgical non-infectious diarrhea.

Other: Florajen Digestion

Interventions

Florajen Digestion OTHER

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.

Also known as: Placebo

Placebo Group; Probiotics Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Related Publications (1)

• 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.

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Reza Saidi

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minakshi Roy

CONTACT

315-464-5413; roym@upstate.edu

Terry Podolak

CONTACT

315-464-5413; podolakt@upstate.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, double-blinded, placebo-controlled, single-center pilot/exploratory trial

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 29, 2023
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 13, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share