An observational study in Common Variable Immunodeficiency and Vascular Diseases, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-01.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
54 studies on the registry are indexed under Common Variable Immunodeficiency; 13 are open to participants now.
This study's planned enrollment of 40 is below the median of 119 across 13 observational studies indexed under Common Variable Immunodeficiency.
Browse Common Variable Immunodeficiency studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Adult patients diagnosed with common variable immunodeficiency associated with enteropathy and with or without portosinusoidal vascular disease.
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Patients with a common variable immunodeficiency according to immune deficiencies classification associated with :
Exclusion Criteria:
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
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.
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
Time frame: 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
Time frame: Day 7
Fecal calprotectin measurement
Evaluate the contribution of fecal calprotectin measurement at diagnosis
Time frame: Day 7
Start is estimated for Jul 2022; primary completion for Dec 2023, 17 months later.
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This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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