Celiac DiseaseNCT01909050
Immune Response in Celiac Disease on In-vitro Gluten Challenge
An observational study of Celiac Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The main purpose of this study is to see how cells taken from the lining of the intestine behave in the laboratory with exposure to gluten and other substances that act on the immune system. The cells lining the intestine of a person with celiac disease should be different than a person without celiac disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Celiac Disease
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Mar 2018
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be selected from patients undergoing a clinically indicated upper endoscopy at Beth Israel Deaconess Medical Center
Who may be able to join
- 18-75 years of age
- Undergoing a clinically indicated upper endoscopy
Who cannot join
- Anticoagulation or antiplatelet therapy
- Known active non-celiac intestinal inflammatory disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: An In-vitro Gluten Challenge on the Immunologic Response in Celiac Disease.
The main purpose of this study is to see how cells taken from the lining of the intestine behave in the laboratory with exposure to gluten and other substances that act on the immune system. The cells lining the intestine of a person with celiac disease should be different than a person without celiac disease. The study doctors would like to see how the cells react after coming in contact with gluten and if substances that act on the immune system can prevent gluten related inflammation. Examples of these substances include steroids. The cells should produce chemicals of their own in response to the gluten. These other chemicals will be measured and the results compared between those with:
- celiac disease that does not respond to a gluten-free diet (refractory celiac disease)
- celiac disease which is controlled by a gluten-free diet
- uncontrolled celiac disease (either newly diagnosed with celiac disease or not on a gluten-free diet
- gluten-sensitivity
- disorders other than celiac disease.
Read the detailed description
The primary purpose of this study is to determine the effect of in-vitro introduction of gluten on inflammatory response primarily Interferon-γ and other cytokines, such as IL-15, IL-18 and IL-21, in cultures obtained from small intestinal mucosal biopsy samples of subjects who underwent upper endoscopy.
Secondary goals include comparing the inflammatory response to immunosuppressants and cytokines after exposing the cultures obtained from small intestinal mucosal biopsies taken from RCD I subjects with intestinal mucosal biopsies taken from subjects with CeD controlled on a Gluten-Free Diet (GFD), uncontrolled CeD, Gluten sensitivity and Non-celiac Controls.
- Conditions
- Celiac Disease
- Keywords
- celiac disease, refractory celiac disease, gluten sensitivity
- Medical subject headings
- Celiac Disease
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 |
|---|---|---|
| refractory celiac disease | Not described | |
| well-controlled celiac disease | Not described | |
| uncontrolled celiac disease | either newly diagnosed with celiac disease or not on a gluten-free diet | |
| gluten-sensitivity | Not described | |
| disorders other than celiac disease. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in interferon gamma
in vitro culture stimulated with gluten
Measured: 0, 6, and 24 hours
Secondary outcomes (3)
change in interleukin-15
in vitro culture stimulated with gluten
Measured: 0, 6, and 24 hours
change in interleukin-18
in vitro culture stimulated with gluten
Measured: 0, 6, and 24 hours
change in interleukin-21
in vitro culture stimulated with gluten
Measured: 0, 6, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess 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
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Leffler, Beth Israel Deaconess Medical Center
- Investigators
- Daniel A Leffler, MD, MS, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909050
- Sponsor's protocol ID
- 2012P000354
- Status last verified
- Mar 2018
- First submitted
- 18 Jul 2013
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In-vitro Gluten Challenge on the Immunologic Response in Celiac Disease.
- ClinicalTrials.gov ID
- NCT01909050
- Acronym / sponsor ID
- 2012P000354
- Conditions
- Celiac Disease
- Keywords
- celiac disease, refractory celiac disease, gluten sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 26 Jul 2013 (estimated)
- 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 main purpose of this study is to see how cells taken from the lining of the intestine behave in the laboratory with exposure to gluten and other substances that act on the immune system. The cells lining the intestine of a person with celiac disease should be different than a person without celiac disease. The study doctors would like to see how the cells react after coming in contact with gluten and if substances that act on the immune system can prevent gluten related inflammation. Examples of these substances include steroids. The cells should produce chemicals of their own in response to the gluten. These other chemicals will be measured and the results compared between those with:
- celiac disease that does not respond to a gluten-free diet (refractory celiac disease)
- celiac disease which is controlled by a gluten-free diet
- uncontrolled celiac disease (either newly diagnosed with celiac disease or not on a gluten-free diet
- gluten-sensitivity
- disorders other than celiac disease.
Detailed description
The primary purpose of this study is to determine the effect of in-vitro introduction of gluten on inflammatory response primarily Interferon-γ and other cytokines, such as IL-15, IL-18 and IL-21, in cultures obtained from small intestinal mucosal biopsy samples of subjects who underwent upper endoscopy.
Secondary goals include comparing the inflammatory response to immunosuppressants and cytokines after exposing the cultures obtained from small intestinal mucosal biopsies taken from RCD I subjects with intestinal mucosal biopsies taken from subjects with CeD controlled on a Gluten-Free Diet (GFD), uncontrolled CeD, Gluten sensitivity and Non-celiac Controls.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| refractory celiac disease | – | – |
| well-controlled celiac disease | – | – |
| uncontrolled celiac disease | – | –either newly diagnosed with celiac disease or not on a gluten-free diet |
| gluten-sensitivity | – | – |
| disorders other than celiac disease. | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from patients undergoing a clinically indicated upper endoscopy at Beth Israel Deaconess Medical Center
Key inclusion criteria (2 listed)
- 18-75 years of age
- Undergoing a clinically indicated upper endoscopy
Key exclusion criteria (2 listed)
- Anticoagulation or antiplatelet therapy
- Known active non-celiac intestinal inflammatory disorder
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
change in interferon gamma
Time frame: 0, 6, and 24 hours
in vitro culture stimulated with gluten
3 secondary outcomes
change in interleukin-15
Time frame: 0, 6, and 24 hours
change in interleukin-18
Time frame: 0, 6, and 24 hours
change in interleukin-21
Time frame: 0, 6, and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
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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.
Daniel A Leffler, MD, MS principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in interferon gamma (time frame: 0, 6, and 24 hours). 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 19 Mar 2018.