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临床试验/NCT05481554
NCT05481554Unknown不适用

Composition and Function of Gut Microbiota in Porto-sinusoidal Vascular Disease Associated With Variable Common Immunodeficiency

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Occurrence of a dysbiosis

研究概览

简要总结

This aim of this study is the evaluation of the gut microbiota imbalance occurrence and its characterization in patients with common variable immunodeficiency associated to an enteropathy with or without porto-sinusoidal vascular disease.

详细描述

Common variable immunodeficiency (CVID) is the most common symptomatic humoral deficiency in adults and is accompanied by digestive symptoms. It is associated with intestinal dysbiosis and half of the patients exert a clinical digestive disease, called enteropathy. Hepatic complications characterized by porto-sinusoidal vascular disease are observed in 10% of the CVID patients. This complication is associated with a high morbi-mortality. In our center experience and in the literature, clinical occurrence of enteropathy and hepatic disease are highly correlated. Considering (i) the anatomical link between the intestinal tractus and the portal circulation, (ii) the clinical correlation between enteropathy and the liver disease and (iii) the established relation between gut microbiota and alcoholic cirrhosis, we speculate that patients whom develop portosinusoidal complications exert a peculiar intestinal dysbiosis.

This study could contribute to a better understanding of the hepatic disease development, hence allowing us to suggest novel therapies based on gut microbiota modification.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age ≥ 18 years
  • Patients with a common variable immunodeficiency according to immune deficiencies classification associated with :
  • enteropathy and porto-sinusoidal vascular disease
  • enteropathy without porto-sinuoidal vascular disease
  • Subject with health insurance (AME excepted)
  • Verbal agreement to participate at the study

排除标准

  • Laxatives in the month preceding stool sample

结局指标

主要结局

Occurrence of a dysbiosis

时间窗: Day 7

Evaluate the occurrence of dysbiosis and characterize gut microbiota (function and composition) by genomic (16S) and metabolomic (short chain fatty acids, bile acids, tryptophan metabolites) analyses from stool samples of patients with a common variable immunodeficiency with only enteropathy compared to patients with common variable immunodeficiency with enteropathy and porto-sinusoidal vascular disease

Characterization of gut microbiota

时间窗: Day 7

Evaluate the occurrence of dysbiosis and characterize gut microbiota (function and composition) by genomic (16S) and metabolomic (short chain fatty acids, bile acids, tryptophan metabolites) analyses from stool samples of patients with a common variable immunodeficiency with only enteropathy compared to patients with common variable immunodeficiency with enteropathy and porto-sinusoidal vascular disease

次要结局

  • Fecal calprotectin measurement(Day 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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