Immunological Characteristics of Patients With PID and IBD

May 8, 2017 updated by: Sheba Medical Center

Immunological Characteristics of Patients With Primary Immunodeficiencies and Inflammatory Bowel Diseases

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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Be'er Sheba, Israel
        • Not yet recruiting
        • Soroka University Medical Center
        • Principal Investigator:
          • Baruch Yerushalmi
        • Contact:
      • Tel Hashomer, Israel
        • Recruiting
        • Edmond and Lily Safra Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a known or unknown immunodeficiency who develop inflammatory bowel disease or are suspected to have such a condition.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PID IBD patients
patients with an immunodeficiency and inflammatory bowel disease phenotype

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of immune cells
Time Frame: 3 years
Frequency of pro- and anti-inflammatory immune cell subsets including functional analysis
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of stool microbiome
Time Frame: 3 years
16S analysis to identify changes in diversity and specific taxa
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Dror S Shouval, MD, Edmond and Lily Safra Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2017

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

April 27, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (Actual)

May 10, 2017

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-17-3824-DS-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammatory Bowel Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe