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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02267-34 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool sample | Biological | Only 1 stool sample will be collected during the patient hospitalisation scheduled within standard care. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal calprotectin measurement | Evaluate the contribution of fecal calprotectin measurement at diagnosis | Day 7 |
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Inclusion Criteria:
Age ≥ 18 years
Patients with a common variable immunodeficiency according to immune deficiencies classification associated with :
Subject with health insurance (AME excepted)
Verbal agreement to participate at the study
Exclusion Criteria:
- Laxatives in the month preceding stool sample
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Adult patients diagnosed with common variable immunodeficiency associated with enteropathy and with or without portosinusoidal vascular disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jehane FADLALLAH, MD, PhD | Contact | 01 42 49 45 83 | jehane.fadlallah@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jehane FADLALLAH, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Immunologie Clinique Hôpital Saint Louis | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D017074 | Common Variable Immunodeficiency |
| D014652 | Vascular Diseases |
| D000094724 | Idiopathic Noncirrhotic Portal Hypertension |
| ID | Term |
|---|---|
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D002318 | Cardiovascular Diseases |
| D006975 | Hypertension, Portal |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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