- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05481554
Composition and Function of Gut Microbiota in Porto-sinusoidal Vascular Disease Associated With Variable Common Immunodeficiency (MI-MVPS)
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jehane FADLALLAH, MD, PhD
- Phone Number: 01 42 49 45 83
- Email: jehane.fadlallah@aphp.fr
Study Locations
-
-
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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
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
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
|
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
|
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
Time Frame: Day 7
|
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
Time Frame: Day 7
|
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
Time Frame: Day 7
|
Evaluate the contribution of fecal calprotectin measurement at diagnosis
|
Day 7
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jehane FADLALLAH, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP211408
- 2021-A02267-34 (OTHER: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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