Celiac DiseaseNCT03152279
Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance
An observational study of Celiac Disease, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Increased intestinal permeability can represent compromise of the epithelium's integrity and is thought to be the primary mechanism in patients who develop Celiac Disease (CeD) and non-celiac gluten sensitivity when gluten peptides cross the barrier and trigger an immune response. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Mucosal Impedance Catheter and Blood sample
- Type of treatment
- Injection or infusion
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 14 Nov 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Celiac disease patients will be identified in the Celiac Disease Clinic at Vanderbilt. Patients will be asked if they would like to participate in the study during their clinic visit and will undergo consent for the study at the time of procedure. Control subjects will be asked about participation at the time of routine endoscopy.
Who may be able to join
- scheduled for endoscopy as part of routine care with or without suspected Celiac Disease based upon at least 1 positive serologic marker of CeD
- consuming gluten at time of endoscopy
Who cannot join
- Already on a gluten free diet or unwilling to undergo a gluten challenge
- Undergoing upper endoscopy for an urgent indication such as unstable gastrointestinal bleed or food impaction
- Patients with inflammatory bowel disease
- Patients on blood thinners other than aspirin at time of endoscopy
- Patient unable to give informed consent
- Patient less than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center Endoscopy Laboratory
Nashville, Tennessee, 37232
About this study
Increased intestinal permeability can represent compromise of the epithelium's integrity and is thought to be the primary mechanism in patients who develop Celiac Disease (CeD) and non-celiac gluten sensitivity when gluten peptides cross the barrier and trigger an immune response. In this study, the investigators propose to use a novel, minimally invasive technology to detect mucosal damage (i.e. barrier dysfunction) in the duodenal epithelium. The primary aim of this study is to identify if there is a difference in duodenal mucosal impedance between CeD and control patients.
- Conditions
- Celiac Disease
- Being tested
- Mucosal Impedance Catheter, Blood sample
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucosal Impedance CatheterDiagnostic test
During routine endoscopy, consented study participants will have a mucosal impedance catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant.
Blood sampleDiagnostic test
At time of endoscopy, subjects with initial positive CeD serology will have a blood sample taken for any missing CeD serologies and intestinal fatty acid-binding protein (IFABP). This will be done at time of IV initiation as to avoid any additional venipuncture.
| Study group | Role | What they receive |
|---|---|---|
| Celiac Disease | Patients with suspected Celiac Disease who plan to undergo duodenal biopsy as part of routine clinical care Receives: Diagnostic Test: Mucosal Impedance Catheter; Diagnostic Test: Blood sample | |
| Control | Patients scheduled for an upper endoscopy for indication other than evaluation of Celiac Disease or concern for CeD as part of routine clinical care Receives: Diagnostic Test: Mucosal Impedance Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
mucosal impedance values
Identify if there is a difference in duodenal mucosal impedance between CeD and control patients
Measured: Values will be obtained at conclusion of esophagogastroduodenoscopy (EGD), an expected average of 6 minutes
Secondary outcomes (2)
Marsh Score
Correlate measures of duodenal impedance with standardized pathology scores in CeD (Marsh Score)
Measured: 1 week
IFABP
Identify whether there is a difference in IFABP in patients with normal and abnormal mucosal impedance
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study startDec 2016
- Primary completion7 Nov 2018
- Study completion14 Nov 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 Vanderbilt University 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhyanesh Patel, Vanderbilt University Medical Center
- Investigators
- Dhyanesh Patel, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152279
- Sponsor's protocol ID
- 161436
- Status last verified
- May 2021
- First submitted
- 10 May 2017
- Last updated
- 6 May 2021
- 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 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance
- ClinicalTrials.gov ID
- NCT03152279
- Acronym / sponsor ID
- 161436
- Conditions
- Celiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 7 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 15 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.
Increased intestinal permeability can represent compromise of the epithelium's integrity and is thought to be the primary mechanism in patients who develop Celiac Disease (CeD) and non-celiac gluten sensitivity when gluten peptides cross the barrier and trigger an immune response. In this study, the investigators propose to use a novel, minimally invasive technology to detect mucosal damage (i.e. barrier dysfunction) in the duodenal epithelium. The primary aim of this study is to identify if there is a difference in duodenal mucosal impedance between CeD and control patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celiac Disease | – | Diagnostic Test: Mucosal Impedance Catheter, Diagnostic Test: Blood samplePatients with suspected Celiac Disease who plan to undergo duodenal biopsy as part of routine clinical care |
| Control | – | Diagnostic Test: Mucosal Impedance CatheterPatients scheduled for an upper endoscopy for indication other than evaluation of Celiac Disease or concern for CeD as part of routine clinical care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Celiac disease patients will be identified in the Celiac Disease Clinic at Vanderbilt. Patients will be asked if they would like to participate in the study during their clinic visit and will undergo consent for the study at the time of procedure. Control subjects will be asked about participation at the time of routine endoscopy.
Key inclusion criteria (2 listed)
- scheduled for endoscopy as part of routine care with or without suspected Celiac Disease based upon at least 1 positive serologic marker of CeD
- consuming gluten at time of endoscopy
Key exclusion criteria (6 listed)
- Already on a gluten free diet or unwilling to undergo a gluten challenge
- Undergoing upper endoscopy for an urgent indication such as unstable gastrointestinal bleed or food impaction
- Patients with inflammatory bowel disease
- Patients on blood thinners other than aspirin at time of endoscopy
- Patient unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mucosal Impedance CatheterDuring routine endoscopy, consented study participants will have a mucosal impedance catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. | Diagnostic test | Celiac Disease, Control |
| Blood sampleAt time of endoscopy, subjects with initial positive CeD serology will have a blood sample taken for any missing CeD serologies and intestinal fatty acid-binding protein (IFABP). This will be done at time of IV initiation as to avoid any additional venipuncture. | Diagnostic test | Celiac Disease |
Primary outcome
mucosal impedance values
Time frame: Values will be obtained at conclusion of esophagogastroduodenoscopy (EGD), an expected average of 6 minutes
Identify if there is a difference in duodenal mucosal impedance between CeD and control patients
2 secondary outcomes
Marsh Score
Time frame: 1 week
IFABP
Time frame: 1 week
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 6 May 2021.
- 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.
Dhyanesh Patel, MD principal investigator
Vanderbilt University 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 Vanderbilt University 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 6 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 6 May 2021. 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?
mucosal impedance values (time frame: Values will be obtained at conclusion of esophagogastroduodenoscopy (EGD), an expected average of 6 minutes). 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 6 May 2021.