NCT05481554

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

June 10, 2022

Last Update Submit

July 28, 2022

Conditions

Common Variable ImmunodeficiencyVascular Diseases

Keywords

Common variable immunodeficiencyPorto-sinusoidal vascular diseaseGut microbiota

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Fecal calprotectin measurement

    Day 7

Study Arms (2)

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

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

Interventions

Stool sampleBIOLOGICAL

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

Common variable immunodeficiency with enteropathyCommon variable immunodeficiency with enteropathy and porto-sinusoidal vascular disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • \- Laxatives in the month preceding stool sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Immunologie Clinique Hôpital Saint Louis

Paris, 75010, France

Location

MeSH Terms

Conditions

Common Variable ImmunodeficiencyVascular DiseasesIdiopathic Noncirrhotic Portal Hypertension

Condition Hierarchy (Ancestors)

Immunologic Deficiency SyndromesImmune System DiseasesCardiovascular DiseasesHypertension, PortalLiver DiseasesDigestive System Diseases

Study Officials

  • Jehane FADLALLAH, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jehane FADLALLAH, MD, PhD

CONTACT

01 42 49 45 83jehane.fadlallah@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2022

First Posted

August 1, 2022

Study Start

July 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

August 1, 2022

Record last verified: 2022-07

Locations

FR(1)