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

Vascular Diseases Clinical Trial

— MI-MVPS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05481554
• Other study ID #: APHP211408
• Secondary ID: 2021-A02267-34
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jehane FADLALLAH, MD, PhD
• Phone: 01 42 49 45 83
• Email: jehane.fadlallah[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Common Variable Immunodeficiency
• Immunologic Deficiency Syndromes
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
France	Immunologie Clinique Hôpital Saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of a dysbiosis	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	Day 7
Primary	Characterization of gut microbiota	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	Day 7
Secondary	Fecal calprotectin measurement	Evaluate the contribution of fecal calprotectin measurement at diagnosis	Day 7