Clinical trial NCT05481554: Composition and Function of Gut Microbiota in Porto-sinusoidal Vascular Disease Associated With Variable Common Immunodeficiency
Official title: Composition and Function of Gut Microbiota in Porto-sinusoidal Vascular Disease Associated With Variable Common Immunodeficiency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Common Variable Immunodeficiency
Vascular Diseases
Keywords: Common variable immunodeficiency
Porto-sinusoidal vascular disease
Gut microbiota
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with common variable immunodeficiency associated with enteropathy and with or without portosinusoidal vascular disease.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of a dysbiosis
timeFrame: Day 7
measure: Characterization of gut microbiota
timeFrame: Day 7
Secondary outcomes:
measure: Fecal calprotectin measurement
timeFrame: Day 7
Other outcomes:
Locations:
city: Paris
country: France
facility: Immunologie Clinique Hôpital Saint Louis
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jehane FADLALLAH, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: