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

NCT02909244 | Completed

• 1 other identifier: IMIS2014-02
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 3

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.

Conditions

Primary Immune Deficiencies

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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: Biological sampling

Control patients, with no PID

Biological sampling: collection of feces.

Biological: Biological sampling

Interventions

Biological sampling BIOLOGICAL

Biological sampling

Control patients, with no PID; Patients with PID

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inclusion of patients with PID Inclusion of control patients, without PID

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Imagine Institute: lead
• Saint Antoine University Hospital: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (3)

CHRU

Lille, 59037, France

Location

Saint-Louis Hospital

Paris, 75010, France

Location

Necker - Enfants Malades Hospital

Paris, 75015, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Feces samples collected on all patients for study of gut microbiota

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sylvain Latour

  Imagine Institute

  STUDY DIRECTOR

• Alain Fischer

  Imagine Institute

  STUDY CHAIR

• Harry Sokol

  Saint-Antoine Hospital

  STUDY CHAIR

• Olivier Join-Lambert

  Necker - Enfants malades Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 21, 2016
• Study Start: February 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 25, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)