Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response?
ConditionCeliac Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOslo University Hospital
About this trial
The goal of this clinical trial is to evaluate the immune response to gluten in patients with celiac disease (CeD) by comparing different forms of gluten administration. The participant population includes adults diagnosed with CeD, who are adhering to a gluten-free diet (GFD). The main questions it aims to answer are:
* Does liquid gluten administration elicit a higher IL-2 cytokine response compared to solid gluten administration? * What is the relationship between serum IL-2 levels and gluten peptide serum concentrations following gluten challenges?
Researchers will compare the responses of two groups: participants receiving liquid gluten (shake) to those receiving solid gluten (cookie) to determine if there is a significant difference in the IL-2 response rates between the two forms.
Participants will be asked to:
* Undergo two gluten challenges (liquid and solid) in a randomized order with at least 4 weeks apart. * Provide blood samples before and after each challenge to measure serum IL-2 levels and gluten peptide concentrations over a period of 6 hours. * Report any symptoms experienced following each gluten challenge.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI 18-33 kg/m2
Willingness to comply with the study procedure and having signed informed, written consent
Previous diagnosis of coeliac disease according to established guidelines based on positive serology (Endomysium test, IgA-TG2 and/or IgG-DGP) (diagnosed in childhood) and a duodenal biopsy showing villous atrophy graded as Marsh 3 according to guidelines from European Society for Study of Coeliac Disease .
Strict adherence to a gluten-free diet at least the 12 last months.
Disqualifiers
Positive serology (IgA-TG2 below upper level of normal) at screening visit
Pregnancy or breast feeding. Fertile women must use effective contraception.
Other inflammatory disease like uncontrolled hypothyreosis, type 1 diabetes, cardiovascular diseases, thyroid and renal disorders, inflammatory bowel diseases or any other disease that in the opinion of the responsible clinician makes the patient unsuitable for the study
Using of immunosuppressive/steroid medications
Trial design
Design model
Crossover
Treatments tested in this trial
Vital wheat gluten
Dietary supplementGluten-containing shake vs gluten-containing cookie
Vital wheat gluten
Dietary supplementHalf of participants will receive gluten-containing shake first, then gluten-containing cookie next, and vice versa
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Gluten shakeActive comparator 1 intervention
Group B: Gluten cookieActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Comparison of serum IL-2 response rates between the gluten shake group and the cookie group
A responder is defined as an individual exhibiting a log-transformed cytokine level equal to or greater than 0. This level corresponds to 1.0 pg/ml in concentration of IL-2 in serum. The hypothesis is that there is a higher proportion of responders in the gluten shake group compared to the cookie group.
Time frame
From baseline to 4 hours at visit 1Secondary outcomes
1
Correlation between serum IL-2 response levels and baseline whole blood plasma IL-2
Time frame
From baseline to 6 hours after gluten intake2
Correlation between serum IL-2 response levels and baseline number of gluten-specific T cells
Time frame
From baseline to 6 hours after gluten intake3
Correlation between serum IL-2 response levels and symptom severity
Time frame
From baseline to 6 hours after gluten intake4
Comparison of serum IL-2 response levels and serum gluten peptide levels
Time frame
From baseline to 6 hours after gluten intakeSponsors and contacts
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Source ClinicalTrials.gov