Inflammatory Bowel DiseasesNCT03148028
Immunological Characteristics of Patients With PID and IBD
An observational study of Inflammatory Bowel Diseases and Primary Immune Deficiency Disorder, run by Sheba Medical Center at 2 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Primary Immune Deficiency Disorder
- How many people
- 45 participants
- Where
- 2 sitesIsrael
- Study dates
- 15 May 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with a known or unknown immunodeficiency who develop inflammatory bowel disease or are suspected to have such a condition.
Who may be able to join
- age <18 years
- diagnosis of an immunodeficiency
- suspected or confirmed IBD
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Not yet recruiting
Soroka University Medical Center
Be'er Sheba
Baruch Yerushalmi, shalmi@bgu.ac.il
Baruch Yerushalmi
- Recruiting
Edmond and Lily Safra Children's Hospital
Tel HaShomer
Dror Shouval, 97235305006, dror.shouval@gmail.com
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Inflammatory Bowel Diseases, Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PID IBD patients | patients with an immunodeficiency and inflammatory bowel disease phenotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of immune cells
Frequency of pro- and anti-inflammatory immune cell subsets including functional analysis
Measured: 3 years
Secondary outcomes (1)
Characterization of stool microbiome
16S analysis to identify changes in diversity and specific taxa
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start15 May 2017 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dror S Shouval, MD, Principal investigator, Edmond and Lily Safra Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148028
- Sponsor's protocol ID
- SHEBA-17-3824-DS-CTIL
- Status last verified
- May 2017
- First submitted
- 27 Apr 2017
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Characteristics of Patients With Primary Immunodeficiencies and Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT03148028
- Acronym / sponsor ID
- SHEBA-17-3824-DS-CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 15 May 2017 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PID IBD patients | – | –patients with an immunodeficiency and inflammatory bowel disease phenotype |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with a known or unknown immunodeficiency who develop inflammatory bowel disease or are suspected to have such a condition.
Key inclusion criteria (3 listed)
- age <18 years
- diagnosis of an immunodeficiency
- suspected or confirmed IBD
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of immune cells
Time frame: 3 years
Frequency of pro- and anti-inflammatory immune cell subsets including functional analysis
1 secondary outcome
Characterization of stool microbiome
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dror S Shouval, MD principal investigator
Edmond and Lily Safra Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Primary Immune Deficiency Disorder, run by Sheba Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dror S Shouval, MD (+972-3-5305006, dror.shouval@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of immune cells (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.