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

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Common Variable Immunodeficiency; Vascular Diseases

Treatments: Biological: Stool sample

Study type: Observational

Funder types: Other

Identifiers

NCT05481554

APHP211408

2021-A02267-34 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Laxatives in the month preceding stool sample

Trial design

40 participants in 2 patient groups

Common variable immunodeficiency with enteropathy

Description:

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

Treatment:

Biological: Stool sample

Common variable immunodeficiency with enteropathy and porto-sinusoidal vascular disease

Description:

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

Treatment:

Biological: Stool sample