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

State University of New York - Upstate Medical University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Renal Transplantation

Treatments: Other: Florajen Digestion

Study type: Interventional

Funder types: Other

Identifiers

NCT06150287

2044457

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)].

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

70 participants in 2 patient groups, including a placebo group

Probiotics Group

Active Comparator group

Description:

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

Treatment:

Other: Florajen Digestion

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Other: Florajen Digestion