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

• Conditions: Vascular Diseases; Common Variable Immunodeficiency
• Interventions: Biological: Stool sample

• Registration Number: NCT05481554
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study First Submitted: 2022-06-10
• Status Verified: 2022-07
• Study Start: 2022-07
• Study First Submitted QC: 2022-07-28
• Last Update Submitted: 2022-07-28
• Study First Posted: 2022-08-01
• Last Update Posted: 2022-08-01
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Common variable immunodeficiency with enteropathy and porto-sinusoidal vascular disease	Stool sample	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
Common variable immunodeficiency with enteropathy	Stool sample	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

Primary Outcome Measures

Name	Time	Method
Occurrence of a dysbiosis	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	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

Secondary Outcome Measures

Name	Time	Method
Fecal calprotectin measurement	Day 7	Evaluate the contribution of fecal calprotectin measurement at diagnosis

Trial Locations

Locations (1)

Immunologie Clinique Hôpital Saint Louis; 🇫🇷 Paris, France