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

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.

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Key information

Conditions

Primary Immune Deficiencies Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU, Lille, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological sampling

Biological

Biological sampling

Primary outcomes

Number of factors associated with the onset of an inflammatory colitis in patients with three Primary Immuno-Deficiencies, identified in the study population

Time frame: 3 years and 8 months

Sponsors and collaborators

Lead sponsor

Imagine Institute

Other

Collaborators

Assistance Publique - Hôpitaux de Paris
Saint Antoine University Hospital

Registry information

Official study 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)

Acronym: DIPobiota

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Sep 21, 2016
Registry last updated: Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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