Immunological Characteristics of Patients With PID and IBD

NCT ID: NCT03148028

Last Updated: 2017-05-10

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

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-15

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Inflammatory Bowel Diseases Primary Immune Deficiency Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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PID IBD patients

patients with an immunodeficiency and inflammatory bowel disease phenotype

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age \<18 years
* diagnosis of an immunodeficiency
* suspected or confirmed IBD

Exclusion Criteria

* none
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dror S Shouval, MD

Role: PRINCIPAL_INVESTIGATOR

Edmond and Lily Safra Children's Hospital

Locations

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Soroka University Medical Center

Be'er Sheba, , Israel

Site Status NOT_YET_RECRUITING

Edmond and Lily Safra Children's Hospital

Tel Litwinsky, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Dror S Shouval, MD

Role: CONTACT

+972-3-5305006

Facility Contacts

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Baruch Yerushalmi

Role: primary

Dror Shouval

Role: primary

97235305006

Other Identifiers

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SHEBA-17-3824-DS-CTIL

Identifier Type: -

Identifier Source: org_study_id

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