Immunological Characteristics of Patients With PID and IBD

Inflammatory Bowel Diseases Clinical Trial

Official title:

Immunological Characteristics of Patients With Primary Immunodeficiencies and Inflammatory Bowel Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03148028
• Other study ID #: SHEBA-17-3824-DS-CTIL
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2017
• Last updated: May 8, 2017
• Start date: May 15, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2017
• Source: Sheba Medical Center
• Contact: Dror S Shouval, MD
• Phone: +972-3-5305006
• Email: dror.shouval[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators wish to characterize alterations in the architecture and function of immune cells in patients with a primary immunodeficiency that also develop inflammatory bowel disease. In addition, The investigators' goal is to characterize the microbiome of these patients, in order to determine whether specific microbial alterations are related to inflammation.

Description:

The pathogenesis of inflammatory bowel diseases (IBD), like Crohn's disease and ulcerative colitis is complex and is thought to be related to genetic, environmental and microbial alterations that lead to a hyperactive/dysregulated immune system that mediates tissue damage. In rare cases, IBD can develop in patients with primary immunodeficiencies (PID) who develop severe, atypical or recurrent infections. The bowel disease in these patients can present after they develop infectious complications but also prior to that. The goal of the current study is to characterize immune function in patients with PID and IBD in order to identify alterations in pro-inflammatory and regulatory pathways.

The investigators will obtain blood samples from PID patients with IBD in order to perform deep immune profiling using various techniques such as flow cytometry, ELISA and others. Moreover, the investigators wish to characterize the microbiome of these patients. This multi-disciplinary approach will advance our understanding why specific patients with an immunodeficiency develop an IBD-like phenotype.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 31, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• age <18 years

• diagnosis of an immunodeficiency

• suspected or confirmed IBD

Exclusion Criteria:

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Be'er Sheba
Israel	Edmond and Lily Safra Children's Hospital	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of immune cells	Frequency of pro- and anti-inflammatory immune cell subsets including functional analysis	3 years
Secondary	Characterization of stool microbiome	16S analysis to identify changes in diversity and specific taxa	3 years