eutrophil migration in gluten-related diseases

Conditions: Celiac disease
Non-celiac gluten sensitivity

Registration Number: NL-OMON29405

Lead Sponsor: Maastricht University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Adult volunteers, aged 20-60 years old, who belong to one of the following groups:
1. Healthy volunteers without celiac disease (CD) or non-celiac gluten sensitivity (NCGS), who do not state any symptoms after ingesting gluten (n = 20);
2. Biopsy-proven CD patients in remission, on a strict gluten-free diet since at least three months (n = 10);
3. 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 who are on a gluten-free diet since at least three months (n = 10).

Exclusion Criteria

- Gastrointestinal, genitourinary or immune diseases that can affect interpretation of the results;
- 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 non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Our primary goal is to confirm the differences in neutrophil migration behaviour between control and CD patients as observed in the American study, for the Dutch situation, and to add to the study a third group, NCGS patients, in order to get insight in both gluten-related diseases allowing us to develop a diagnostic kit based on the obtained results.<br> <br>For this purpose, part of the blood that will be collected once by venepuncture (using EDTA tubes) during the single visit will be used to set up the 2D-underagarose migration assay to investigate neutrophils migration to gluten in these three study groups.

Secondary Outcome Measures

Name	Time	Method
We intend to find a panel of biomarkers associated with the migration capacity by performing RNA sequencing in all three study groups, using part of the blood sample that will be collected by venepuncture (using EDTA tubes) during the single visit. This approach largely increases the possibility to find shared values and differences between the groups and allows us to get better understanding of the underlying mechanisms that are at the basis of the observed neutrophil migration behavior.<br> <br>Since virtually all CD patients carry HLA-DQ2/DQ8 haplotypes (>97%) we will determine these haplotypes in our participants in order to properly define the study groups. We will also measure celiac markers in serum at time (using the blood collected in the 8mL serum collection-tube) of assay as an essential check for the in-remission state of the disease in CD patients and to exclude CD in our healthy control group.