Determination of neutrophils response to gluten and development of a novel less invasive assay to diagnose gluten-related diseases.
- Conditions
- celiac diseaseGluten intolerance10017969
- Registration Number
- NL-OMON54481
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Age: 20-60 years old
Furthermore:
- Biopsy proven celiac disease patients in remission, on a strict gluten-free
diet since at least 3 months
OR
- Non-celiac gluten sensitive (NCGS) patients, reporting gastrointestinal or
extra-intestinal symptoms within 8 hours after gluten consumption, in whom
celiac disease has been ruled out by means of serology and/or biopsy, and on a
gluten-free diet since at least 3 months
OR
- Healthy volunteers without celiac disease or NCGS, who do not state any
symptoms after ingesting gluten
- Gastrointestinal, genitourinary or immune diseases that can affect
interpretation of the results
- Pregnancy
- Use of antibiotics or immunosuppressive drugs within 90 days prior to the
study
- Excessive use of drugs or alcohol
- Participation in any other scientific study that may interfere with the
present study
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Our primary goal is to confirm the differences in neutrophil migration<br /><br>behaviour between control and celiac disease patients as observed in the<br /><br>American study, for the Dutch situation, and to add non-celiac<br /><br>glutensensitivity patients* neutrophils to the study in order to get insight in<br /><br>both gluten-related diseases that allows us to develop a diagnostic kit based<br /><br>on the obtained results. For this purpose we will set up the migration assay to<br /><br>investigate neutrophils migration to gluten in these three study groups. </p><br>
- Secondary Outcome Measures
Name Time Method