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

NCT ID: NCT02909244

Last Updated: 2017-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-02-28

Brief Summary

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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

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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.

Conditions

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Primary Immune Deficiencies

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with PID

Biological sampling: collection of feces. In case of blood samples availability in hospital biobank : analyzes of these samples in the frame of this research

Biological sampling

Intervention Type BIOLOGICAL

Biological sampling

Control patients, with no PID

Biological sampling: collection of feces.

Biological sampling

Intervention Type BIOLOGICAL

Biological sampling

Interventions

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Biological sampling

Biological sampling

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Presenting a Primary Immune Deficiency (CGD, XIAP ou TTC7A deficiency) with or without inflammatory digestive disease


* No antibiotic treatment in the month preceding the inclusion

Exclusion Criteria

* Patients having a received a gene therapy or a Hematopoietic stem cell transplantation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint Antoine University Hospital

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role collaborator

Imagine Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvain Latour

Role: STUDY_DIRECTOR

Imagine Institute

Alain Fischer

Role: STUDY_CHAIR

Imagine Institute

Harry Sokol

Role: STUDY_CHAIR

Saint-Antoine Hospital

Olivier Join-Lambert

Role: STUDY_CHAIR

Necker - Enfants malades Hospital

Locations

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CHRU

Lille, , France

Site Status

Saint-Louis Hospital

Paris, , France

Site Status

Necker - Enfants Malades Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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IMIS2014-02

Identifier Type: -

Identifier Source: org_study_id

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