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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Reduction in immunosuppressive drugs-associated diarrhea [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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.

Идентификаторы

NCT: NCT06150287 · 2044457

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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