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Modulation of Gut Microbiota in End-stage Renal Disease (MGM-dialysis)

2017년 12월 12일 업데이트: Medical University of Graz

Modulation of Gut Microbiota in End-stage Renal Disease: A Pilot Study

In end-stage renal disease (ESRD) cardiovascular and infectious complications are common. The gut microbiome might play an important pathophysiological role. ESRD is hypothesized to be associated with profound alterations of gut microbiome and gut permeability. The investigators aim to test whether a multispecies probiotic mixture is able to revert the microbiome changes and decrease gut permeability. Furthermore the investigators aim to test whether this improvement in microbiome composition and gut permeability is also associated with improvements in endotoxemia, uremia and cardiovascular risk factors.

연구 개요

상세 설명

Chronic kidney disease (CKD) has a prevalence of 10% in the general population and up to 20% in high-risk groups, such as patients with diabetes. Despite the widespread availability of renal replacement therapy in the western world, mortality of patients with end-stage renal disease (ESRD) is still high. The life expectancy of patients with renal replacement therapy in Austria is reduced by more than 50%.

Patients on renal replacement therapy exhibit an increased cardiovascular mortality (10-30 fold higher than in the general population) associated with accelerated vascular calcification. The KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES (KDIGO)-work group introduced the term CKD-Mineral and Bone Disorder (CKD-MBD) which describes a clinical syndrome encompassing mineral, bone, and calcific cardio-vascular abnormalities that develop as a complication of CKD. This syndrome emerges as a result of a declining kidney function and is characterized by changes of circulating levels of parathyroid hormone (PTH), 25-hydroxyvitamin D (25(OH)D),1,25-dihydroxyvitamin D (1,25(OH)2D), other vitamin D metabolites and fibroblast growth factor-23 (FGF-23). The ability of the failing kidneys to excrete phosphate is diminished and hyperphosphatemia occurs. High phosphate levels together with calcium as well as low concentrations of fetuin A, the main calcification inhibitor under physiological conditions, lead to increased vascular and extravascular calcification and renal bone disease. Another important calcification inhibitor is the vitamin K2-dependent matrix Gla-protein (MGP). Dialysis patients exhibit a low vitamin K intake and suffer substantially from vitamin K deficiency. Insufficient vitamin K intake leads to the production of non-carboxylated, inactive MGP and deficiency of carboxylated MGP may contribute substantially to the development and progression of arterial calcification. Bacterial infection and sepsis, although decreasing over the last decades, also account for up to 20% of deaths in ESRD-patients and are the second most common cause of mortality and hospitalization. Mortality due to sepsis is 100 - 300 times higher in dialysis patients as compared to the general population. The mechanisms of the increased susceptibility to infection are unclear but recent studies suggest that in patients with ESRD, innate immune response is defective. One reason for defective innate immunity might lie in an increased risk for endotoxemia. Hemodialysis (HD)-induced regional splanchnic ischemia leads to increased gut permeability and consecutive endotoxin translocation. This possibly results in alterations in gut microbiome composition.

Recently profound alterations of the composition of the gut microbiome in ESRD have been shown. In ESRD subjects, more Firmicutes, Actinobacteria and Proteobacteria and fewer Sutterellaceae, Bacteroidaceae, and Lactobacillaceae were observed relative to controls. The frequent use of antibiotics, phosphate binders and an often polypragmatic drug consumption has a considerable impact on the microbiome of ESRD-patients.

These alterations of gut microbiota can impact on several mechanisms in ESRD. Gut bacteria produce vitamin K and the microbiome composition might therefore play a pivotal role in providing enough vitamin K for a sufficient carboxylation of MGP, a potent inhibitor of arterial calcification. Treatment with vitamin K antagonists, for example, has been associated with a 10 fold increased risk for the development of calcification and calciphylaxis, a life threatening calcifying arteriolopathy in CKD-patients. Furthermore the gut is a potential source of endotoxin in patients with ESRD, due to translocation of bacterial products across the gastrointestinal barrier. In ESRD the presence of endotoxin is an independent predictor for mortality. Ultrafiltration during hemodialysis treatment leads to critical ischemia in the splanchnic vascular bed, thus adversely affecting the integrity of the gut barrier. Disruption of gut barrier function in ESRD allows translocation of endotoxin and bacterial metabolites to the systemic circulation, which contributes to inflammation and uremia and prompts progression of the disease. Furthermore, subclinical inflammation in ESRD-patients has been shown to promote progression of cardiovascular disease as well. The gut microbiome also impacts on glucose metabolism and plays a critical role in obesity and the development of insulin resistance and type 2 diabetes. Protein fermentation by gut microbiota generates toxic metabolites and many of the known uremic toxins are of intestinal origin, including p-cresol and indoxyl sulfate. Modulation of the microbiome can contribute to the reduction/elimination of uremic toxins.

Improving the poor prognosis of ESRD patients is an ongoing challenge. An increased awareness of the limitations in conventional dialysis techniques has renewed interest in alternative therapeutics in recent years. An unmet clinical need for adjuvant therapeutic strategies persists in patients whether renal transplantation is intended or not. Supplementation of probiotics and thereby targeting the intestine, an important source of endotoxin and uremic toxins, might be a promising approach to partly overcome the high morbidity and mortality in ESRD patients. Probiotics are living beneficial microorganisms, able to gastroduodenal passage and maintain viability throughout the gut. Feasibility of gut microbiome modulation in ESRD was shown in animal and human settings. However, so far, it is unknown to what extend probiotics are able to re-establish gut microbiome homeostasis in ESRD. Furthermore the effects of a probiotic intervention on cardiovascular risk factors, inflammation, gut barrier and uremia have not been studied in detail yet.

연구 유형

중재적

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Graz, 오스트리아, 8010
        • Department of Internal Medicine, Medical University of Graz

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Informed consent
  • Patients with end-stage renal disease [5] undergoing any modality of renal replacement therapy (hemodialysis, hemodiafiltration or peritoneal dialysis)

Exclusion Criteria:

  • Malignancy
  • Pregnancy
  • Chronic inflammatory bowel disease
  • Celiac disease
  • Active alcohol abuse (>40g alcohol per day)
  • Any severe organ dysfunction unrelated to renal dysfunction

    20 healthy family members (living in the same household) of patients will be recruited as controls

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Probiotic
6 g of Winclove-849 containing Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19, Lactococcus lactis W58 at a concentration of 2.5 x 109 cfu/g
multispecies probiotic
위약 비교기: Placebo
similar looking and tasting placebo without bacteria
matrix

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Gut microbiome
기간: 1 year
changes in gut microbiome composition
1 year

2차 결과 측정

결과 측정
측정값 설명
기간
gut permeability (zonulin in stool)
기간: 1 year
changes in gut permeability
1 year
bacterial translocation (bacterial DNA in serum)
기간: 1 year
decrease in bacterial translocation
1 year
neutrophil phagocytic capacity
기간: 1 year
improvement in neutrophil function
1 year
glucose metabolism (meal tolerance test)
기간: 1 year
improvement in glucose metabolism
1 year
uremia toxins
기간: 1 year
decrease in uremia toxins
1 year

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Vanessa Stadlbauer, MD, Medical University of Graz
  • 수석 연구원: Harald Sourij, MD, Medical University of Graz

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2017년 1월 1일

기본 완료 (예상)

2020년 1월 1일

연구 완료 (예상)

2021년 1월 1일

연구 등록 날짜

최초 제출

2015년 7월 29일

QC 기준을 충족하는 최초 제출

2015년 10월 2일

처음 게시됨 (추정)

2015년 10월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 12월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 12월 12일

마지막으로 확인됨

2017년 12월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 26-255 ex 13/14

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Probiotic에 대한 임상 시험

3
구독하다