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临床试验/NCT04428190
NCT04428190招募中1 期

Prebiotic Therapy to Improve Outcomes of Renal Transplant

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月23日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Short Form Health Survey (SF-36)

研究概览

简要总结

An investigator initiated pilot study: two arm, double blind, placebo controlled, randomized, group of approximately 60 patients undergoing a kidney transplant. Participants will be treated with human milk oligosaccharide (HMO) prebiotic versus placebo over 12 weeks from start of the investigational medication date (approximately 3 months) to test whether HMO can improve renal transplant outcomes. Participants will be followed up for 3 months after after they complete the treatment portion of the study. HMO sachets will be administered to determine the safety and efficacy of HMO relative to placebo in improving renal transplant outcomes in patients by reducing delayed graft function and side effects from post transplant therapy.

详细描述

Nearly three million people worldwide suffer from end stage renal disease (ESRD), which has debilitating consequences on the quality of life of patients There is a discrepancy between the availability of organs and the increasing number of patients placed on the waiting list. Canadians with ESRD requiring kidney transplantation has increased by 38% from 2005-2014, whereas the number of transplantable organs has not met this growing need.

As clinicians use more marginal donors, the effects of ischemic injury from the procurement process become more pronounced. This ischemia reperfusion injury (IRI) has been linked to increased delayed graft function, rejection and decreased long-term function. Approximately 20% of transplanted patients subsequently return to dialysis due to poor graft function. Therefore, one of the major goals of the transplant community has now shifted to ensuring the longevity of transplanted organs. Research priorities need to shift towards developing ways to ensure the longevity of grafts through modification of recipient factors.

Patients are also required to remain on immunosuppressive drugs following transplant in order to maintain the graft. These have a variety of side effects, including diarrhea and intestinal malabsorption, which can lead to a lack of patient compliance with post transplant therapy and a reduced quality of life.

Patients with ESRD also have an expansion of bacteria that produce urease and uric acid and produce fewer short-chained fatty acids and vitamins.

This is important as it is theorized that the production of short-chained fatty acids by microorganisms in the GI tract are crucial as both the energy source, and to the maintenance of intestinal permeability, which contribute to a healthy gastrointestinal tract.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

No other parties will be masked for the study.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 years of age and over receiving a kidney transplant.

排除标准

  • •Under 18 years of age
  • •Inability to give consent
  • •Usage of probiotics or other prebiotics.
  • •Have had carcinomas during the last 5 years
  • •Bowel surgery
  • •Crohn ́s disease and other conditions.

研究组 & 干预措施

Placebo

Placebo Comparator

10 g sachet, self-administered for 3 months.

Placebo sachets are identical to the HMO sachets in color, taste, smell, size and shape

干预措施: Placebo (Other)

Human Milk Oligosaccharide (HMO)

Active Comparator

10 g sachet, self-administered for 3 months.

2'-O-fucosyllactose and lacto-N-neotetraose, novel human milk oligosaccharide (HMO) sugars have been shown to stimulate the production of short chain fatty acids, especially propionate. Propionate has been shown to be important in attenuating hypertrophy, fibrosis, vascular dysfunction and hypertension (Bartolomaeus H et al 2019Mar12) and extremely important for the gut kidney axis (Li L et al 2017Dec11).

干预措施: Human Milk Oligosaccharides (HMO) (Dietary Supplement)

结局指标

主要结局

Short Form Health Survey (SF-36)

时间窗: 24 weeks

The Short Form Health Survey will measure participant satisfaction using a scale from 1 - 5, 1 being the best outcome, and 5 being the worst outcome.

Adverse Events

时间窗: 24 weeks

Adverse events will be recorded through case report forms and reported to the principal investigator. Side effects will be assessed using standardized case report forms at each visit. Participants are encouraged to contact the coordinator to report any concerns.

次要结局

  • Microbiome changes post intervention(12 weeks)
  • Microbiome changes from baseline to end of treatment(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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