Effect of Probiotics on Immunosuppressive-drug-associated Diarrhea Among Renal Transplant Recipients
NCT ID: NCT06150287
Last Updated: 2024-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
70 participants
INTERVENTIONAL
2024-12-31
2027-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Probiotics Group
Participants will receive one probiotics capsule daily for six months immediately after the onset of post-surgical non-infectious diarrhea.
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.
Placebo Group
Participants will receive one placebo capsule daily for six months immediately after the onset of post-surgical non-infectious diarrhea.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 \[(positive for toxin A and B) and enteropathogenic E. coli (positive Shiga toxins)\].
18 Years
80 Years
ALL
No
Sponsors
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State University of New York - Upstate Medical University
OTHER
Responsible Party
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Principal Investigators
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Reza Saidi
Role: PRINCIPAL_INVESTIGATOR
State University of New York - Upstate Medical University
Central Contacts
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References
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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.
Related Links
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Related Info
Other Identifiers
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2044457
Identifier Type: -
Identifier Source: org_study_id
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