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

Brief Title

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

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.
    


Study Type

Observational


Primary Outcome

Occurrence of a dysbiosis

Secondary Outcome

 Fecal calprotectin measurement

Condition

Common Variable Immunodeficiency

Intervention

Stool sample

Study Arms / Comparison 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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

40

Start Date

July 2022

Completion Date

December 2023

Primary Completion Date

December 2023

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jehane FADLALLAH, MD, PhD, 01 42 49 45 83, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT05481554

Organization ID

APHP211408

Secondary IDs

2021-A02267-34

Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris


Study Sponsor

Jehane FADLALLAH, MD, PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris


Verification Date

July 2022