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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Diseases; Common Variable Immunodeficiency
• Intervention / Treatment: Biological: Stool sample

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
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Jehane FADLALLAH, MD, PhD; Phone Number: 01 42 49 45 83; Email: jehane.fadlallah@aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • Immunologie Clinique Hôpital Saint Louis
    • Contact: Jehane FADLALLAH, MD, PhD; Phone Number: 01 42 49 45 83; Email: jehane.fadlallah@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients diagnosed with common variable immunodeficiency associated with enteropathy and with or without portosinusoidal vascular disease.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Common variable immunodeficiency with enteropathy; 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	Biological: Stool sample; Only 1 stool sample will be collected during the patient hospitalisation scheduled within standard care.
Common variable immunodeficiency with enteropathy and porto-sinusoidal vascular disease; 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	Biological: Stool sample; Only 1 stool sample will be collected during the patient hospitalisation scheduled within standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal calprotectin measurement	Evaluate the contribution of fecal calprotectin measurement at diagnosis	Day 7

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Jehane FADLALLAH, MD, PhD, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (ACTUAL): August 1, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Gut microbiota; Common variable immunodeficiency; Porto-sinusoidal vascular disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Immune System Diseases; Vascular Diseases; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency
• Other Study ID Numbers: APHP211408; 2021-A02267-34 (OTHER: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No