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

Primary Immune Deficiencies Clinical Trial

— DIPobiota  

Official title:

Study of Gut Microbiota in Primary Immune Deficiencies, Possibly Associated With Inflammatory Bowel Disease (Chronic Granulomatous Disease, XIAP Gene Deficiency, or TTC7A Gene Deficiency)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909244
• Other study ID #: IMIS2014-02
• Status: Completed
• Phase: N/A
• First received: September 5, 2016
• Last updated: August 24, 2017
• Start date: February 2015
• Est. completion date: February 2017

Study information

• Verified date: August 2017
• Source: Imagine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria (Patients with one of the 3 specific PID mentioned above):

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

Inclusion Criteria (Control patients without one of the 3 specific PID mentioned above):

• No antibiotic treatment in the month preceding the inclusion

Exclusion Criteria (all patients):

• Patients having a received a gene therapy or a Hematopoietic stem cell transplantation

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Primary Immune Deficiencies

Intervention

Biological:
• Biological sampling
Biological sampling

Locations

Country	Name	City	State
France	CHRU	Lille
France	Necker - Enfants Malades Hospital	Paris
France	Saint-Louis Hospital	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Imagine Institute	Assistance Publique - Hôpitaux de Paris, Saint Antoine University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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