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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05481554
Acronym
MI-MVPS
Enrollment
40
Registered
2022-08-01
Start date
2022-07-31
Completion date
2023-12-31
Last updated
2022-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Variable Immunodeficiency, Vascular Diseases

Keywords

Common variable immunodeficiency, Porto-sinusoidal vascular disease, Gut microbiota

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.

Interventions

BIOLOGICALStool sample

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of a dysbiosisDay 7Evaluate 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 microbiotaDay 7Evaluate 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

MeasureTime frameDescription
Fecal calprotectin measurementDay 7Evaluate the contribution of fecal calprotectin measurement at diagnosis

Countries

France

Contacts

Primary ContactJehane FADLALLAH, MD, PhD
jehane.fadlallah@aphp.fr01 42 49 45 83

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026