Celiac Disease in ChildrenNCT03244254
Intestinal Fatty Acid-binding Protein (I-FABP) Levels in Pediatric Celiac Patients
An observational study of Celiac Disease in Children, run by Schneider Children's Medical Center, Israel at 1 site in Israel.
Trial summary
A prospective, longitudinal study meant to compare blood levels of I-FABP in pediatric celiac patients during diagnosis to levels under gluten free diet, it's correlation with traditional serology testing and questionnaire regarding patient responsiveness to the gluten free diet, and in comparison to a control group. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Celiac Disease in Children
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2017to Aug 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients undergoing endoscopy at the research hospital.
Who may be able to join
- Children undergoing endoscopy for diagnosis of celiac disease, with elevated serology (TTG more than 3 times the norm), and whose histological Marsh score is 2 or higher.
Who cannot join
- Diseases known to cause elevation in I-FABP levels: Bowel ischemia, inflammatory bowel disease, Primary Biliary Cholangitis, liver failure, biliary duct obstruction, liver malignancy.
- Bowel trauma or abdominal surgery or acute gastroenteritis in the last 3 months
- NSAID use in the last week.
- Intensive daily physical activity (over 1 hour) in the 2 days prior to endoscopy.
- Known genetic disorders (such as Down's syndrome).
- Patients whose TTG was elevated but lower than 3 times the normal range.
Trial locations and contacts
1 site in 1 country.
Raanan Shamir, Prof. contact
Israel1 site
Schneider Children's Medical Center of Israel
Petah Tikva
Assafh Hoofien, Dr., 9720523310096, Laerites@gmail.com
About this study
Official title: I-FABP Levels in Pediatric Celiac Patients in Transition From Active Disease to Remission
A prospective, longitudinal study meant to compare blood levels of I-FABP in pediatric celiac patients during diagnosis to levels under gluten free diet, it's correlation with traditional serology testing and questionnaire regarding patient responsiveness to the gluten free diet, and in comparison to a control group.
Read the detailed description
I-FABP is a reliable marker for intestinal damage and has been proved to respond more swiftly than traditional serology to enterocyte injury in celiac patients who do not a gluten free diet. In this study a pediatric population of celiac patients will be tested for I-FABP levels during initial endoscopic diagnosis and during one year of follow up. Their levels will be compared to a control group of pediatric patients undergoing endoscopy for reasons other than suspicion of celiac disease. During the period of follow up, the test group will undergo repeat testing for I-FABP levels, as well as the traditional follow up testing for serology in celiac patients and a questionnaire regarding. The results will be analyzed in the hope of finding a way to use I-FABP as a more direct, accurate marker of disease activity, and of correlations between it's level and the patient's Marsh score at diagnosis.
- Conditions
- Celiac Disease in Children
- Keywords
- Celiac Disease, Children, I-FABP
- 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 |
|---|---|---|
| Test Group | Children up to 17 years of age at recruitment undergoing endoscopy in order to diagnose or rule out Celiac disease, whose Marsh score at endoscopy is 2 or higher. | |
| Control Group | Children up to 17 years of age undergoing endoscopy as part of abdominal pain workup, whose Celiac serology is negative, and the Marsh score found at endoscopy is 0. |
What is being measured
The primary outcome is the main question the study is designed to answer.
I-FABP levels at diagnosis
Comparison of I-FABP levels at day of enrollment (and endoscopy) between test and control groups.
Measured: 1 day of enrollment
I-FABP levels during remission
Follow-up of I-FABP levels in test groups during follow-up meetings, comparison with other celiac serology taken at follow-up and adherence to gluten free diet (measured using adherence questionnaires)
Measured: 6 months & 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study startNov 2017 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schneider Children's Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Assaf Hoofien, Schneider Children's Medical Center, Israel
- Investigators
- Raanan Shamir, Prof, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244254
- Sponsor's protocol ID
- SchneiderCMCIsraelIFABP
- Status last verified
- Oct 2017
- First submitted
- 6 Aug 2017
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-FABP Levels in Pediatric Celiac Patients in Transition From Active Disease to Remission
- ClinicalTrials.gov ID
- NCT03244254
- Acronym / sponsor ID
- SchneiderCMCIsraelIFABP
- Conditions
- Celiac Disease in Children
- Keywords
- Celiac Disease, Children, I-FABP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Schneider Children's Medical Center, IsraelUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 9 Aug 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.
A prospective, longitudinal study meant to compare blood levels of I-FABP in pediatric celiac patients during diagnosis to levels under gluten free diet, it's correlation with traditional serology testing and questionnaire regarding patient responsiveness to the gluten free diet, and in comparison to a control group.
Detailed description
I-FABP is a reliable marker for intestinal damage and has been proved to respond more swiftly than traditional serology to enterocyte injury in celiac patients who do not a gluten free diet. In this study a pediatric population of celiac patients will be tested for I-FABP levels during initial endoscopic diagnosis and during one year of follow up. Their levels will be compared to a control group of pediatric patients undergoing endoscopy for reasons other than suspicion of celiac disease. During the period of follow up, the test group will undergo repeat testing for I-FABP levels, as well as the traditional follow up testing for serology in celiac patients and a questionnaire regarding. The results will be analyzed in the hope of finding a way to use I-FABP as a more direct, accurate marker of disease activity, and of correlations between it's level and the patient's Marsh score at diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | – | –Children up to 17 years of age at recruitment undergoing endoscopy in order to diagnose or rule out Celiac disease, whose Marsh score at endoscopy is 2 or higher. |
| Control Group | – | –Children up to 17 years of age undergoing endoscopy as part of abdominal pain workup, whose Celiac serology is negative, and the Marsh score found at endoscopy is 0. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients undergoing endoscopy at the research hospital.
Key inclusion criteria (1 listed)
- Children undergoing endoscopy for diagnosis of celiac disease, with elevated serology (TTG more than 3 times the norm), and whose histological Marsh score is 2 or higher.
Key exclusion criteria (6 listed)
- Diseases known to cause elevation in I-FABP levels: Bowel ischemia, inflammatory bowel disease, Primary Biliary Cholangitis, liver failure, biliary duct obstruction, liver malignancy.
- Bowel trauma or abdominal surgery or acute gastroenteritis in the last 3 months
- NSAID use in the last week.
- Intensive daily physical activity (over 1 hour) in the 2 days prior to endoscopy.
- Known genetic disorders (such as Down's syndrome).
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
I-FABP levels at diagnosis
Time frame: 1 day of enrollment
Comparison of I-FABP levels at day of enrollment (and endoscopy) between test and control groups.
I-FABP levels during remission
Time frame: 6 months & 12 months after enrollment
Follow-up of I-FABP levels in test groups during follow-up meetings, comparison with other celiac serology taken at follow-up and adherence to gluten free diet (measured using adherence questionnaires)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
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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.
Raanan Shamir, Prof. contact
Raanan Shamir, Prof study director
Director
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 in Children, run by Schneider Children's Medical Center, Israel at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 4 Oct 2017. 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 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 Assaf Hoofien, Dr. (972523310096, Laerites@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I-FABP levels at diagnosis (time frame: 1 day of enrollment). The study lists 2 primary outcomes in all. 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 4 Oct 2017.