Study of Gut Microbiota in Primary Immune Deficiency, Possibly Associated With Inflammatory Bowel Disease

Completed

• Conditions: Primary Immune Deficiencies
• Interventions: Biological: Biological sampling

• Registration Number: NCT02909244
• Lead Sponsor: Imagine Institute

Brief Summary

Some Primary Immune Deficiencies can be associated with an inflammatory bowel disease, mimicking Crohn disease : the Chronic Granulomatous Disease (CGD), the XIAP deficiency, and the TTC7A deficiency.

This inflammatory bowel disease is frequent but inconstant, raising questions about other factors contributing to the disease. The aim of our study is to analyze, describe and compare the gut microbiota of patients with those primary immune deficiency, with or without intestinal disease.

The investigators can expect, in the long term, to compare on a same patient, the gut microbiota evolution, and to assess the role of gut microbiota modifications on the onset of an inflammatory bowel disease.

Detailed Description

The investigators will include patients (adults or children), with Primary Immune Deficiency (CGD, XIAP or TTC7A deficiencies), and they will collect feces samples from them.

In parallel, as control groups, patients with no inflammatory bowel disease and no primary immune deficiency will be included, and also patients suffering from Crohn's disease without known primary immune deficiency.

The laboratory collaborators will then realize analyzes on the microbiota collected for all patients.

The study team will then analyze the microbiota composition of the different types of patients, and try to identify some factors, associated with the appearance of an inflammatory disease on these patients.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-21
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-24
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PID	Biological sampling	Biological sampling: collection of feces. In case of blood samples availability in hospital biobank : analyzes of these samples in the frame of this research
Control patients, with no PID	Biological sampling	Biological sampling: collection of feces.

Primary Outcome Measures

Name	Time	Method
Number of factors associated with the onset of an inflammatory colitis in patients with three Primary Immuno-Deficiencies, identified in the study population	3 years and 8 months

Trial Locations

Locations (3)

CHRU; 🇫🇷 Lille, France

Saint-Louis Hospital; 🇫🇷 Paris, France

Necker - Enfants Malades Hospital; 🇫🇷 Paris, France