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

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-31

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Common Variable Immunodeficiency Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Common variable immunodeficiency with enteropathy

20 patients with a common variable immunodeficiency associated to enteropathy will be recruited in the study and will be compared with patients with a common variable immunodeficiency associated to enteropathy and porto-sinusoidal vascular disease

Stool sample

Intervention Type BIOLOGICAL

Only 1 stool sample will be collected during the patient hospitalisation scheduled within standard care.

Common variable immunodeficiency with enteropathy and porto-sinusoidal vascular disease

20 patients with common variable immunodeficiency associated to enteropathy and porto-sinusoidal vascular disease will be recruited in the study and will be compared with patients with a common variable immunodeficiency associated to enteropathy

Stool sample

Intervention Type BIOLOGICAL

Only 1 stool sample will be collected during the patient hospitalisation scheduled within standard care.

Interventions

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Stool sample

Only 1 stool sample will be collected during the patient hospitalisation scheduled within standard care.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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