Celiac Disease
Conditions
Keywords
avenins, celiac disease, gluten-free diet, oat, interleukin-8, intestinal fatty acid binding protein
Brief summary
The goal of this clinical trial is to evaluate the tolerability of the oat cultivar Saul, previously characterized by low celiac disease-related immunoreactivity, in adults with celiac disease in sustained clinical and immunological remission The main question the study aims to answer is whether consumption of gluten-free oats of the Saul variety leads to changes in patient-reported symptoms and serological markers. Participants consumed50 g of gluten-free oat flakes daily for 14 consecutive days.
Detailed description
The primary outcomes were changes in serological markers and patient-reported symptoms. Outcome measures were grouped into three categories: routine serum markers, experimental serum markers, and clinical evaluation. 1. Routine serum markers included: (a) CeD-specific autoantibodies, comprising IgA endomysial antibodies (EMA-IgA), IgA tissue transglutaminase antibodies (tTG-IgA), and IgG antibodies against deamidated gliadin peptides (DGP-IgG); (b) high-sensitivity C-reactive protein (hs-CRP), a marker of low-grade systemic inflammation, used to exclude generalized immune activation that could potentially influence experimental serum markers. 2. Experimental serum markers comprised intestinal fatty acid-binding protein (I-FABP) and interleukin-8 (IL-8), which reflect enterocyte integrity and nonspecific mucosal immune activation, respectively. 3. Clinical evaluation involved the assessment of gastrointestinal and extraintestinal symptoms using the Patient-Reported Symptom Questionnaire (PRSQ).
Interventions
DIETARY_SUPPLEMENTcertified gluten-free oats of the Saul variety
Variability in gluten-free oat tolerance in celiac disease in remission has been reported. Many clinical studies lack of specification of the oat cultivar used. In the present study, we evaluated the tolerability of the oat cultivar Saul, previously characterized by low CeD-related immunoreactivity
Sponsors
Faculty Hospital Kralovske Vinohrady
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥18 years * a previously established diagnosis of celiac disease according to the modified ESPGHAN criteria , with seropositivity for EMA-IgA, tTG-IgA, and DGP-IgG at diagnosis, and histological evidence of small-intestinal mucosal damage consistent with Marsh 3a-3c * adherence to a strict gluten-free diet for at least two years * clinical and immunological remission of celiac disease for at least twelve months.
Exclusion criteria
* consumption of gluten-free oats for at least six months prior to study initiation * pregnancy * any other chronic condition, including autoimmune diseases, immunodeficiency (including IgA deficiency), food or other allergies, malignancy, or abnormal liver enzyme activity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in EMA-IgA | Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment) | Change in endomysial antibody IgA (EMA-IgA) titers as a marker of celiac disease activity. |
| Change in tTG-IgA | Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment) | Change in tissue transglutaminase IgA (tTG-IgA, U/mL) levels as a marker of celiac disease activity. |
| Change in DGP-IgG | Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment) | Change in deamidated gliadin peptide IgG (DGP-IgG, U/mL) levels as a marker of celiac disease activity.. |
| Change in hs-CRP | Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment) | Change in high-sensitivity C-reactive protein (hs-CRP, mg/L) levels as a marker of systemic inflammation. |
| Change in I-FABP | Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment) | Change in intestinal fatty acid-binding protein (I-FABP, ng/mL) levels as a marker of enterocyte damage. |
| Change in IL-8 | Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment) | Change in interleukin-8 (IL-8, pg/mL) levels as a marker of mucosal immune activation. |
| Change in PRSQ score | Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment) | Change in patient-reported gastrointestinal and extraintestinal symptoms score (PRSQ, range 0-150; higher scores indicate greater symptom burden) |
Countries
Czechia
Contacts
PRINCIPAL_INVESTIGATORIva Hoffmanová, MD,PhD
Department of Internal Medicine, Second Faculty of Medicine, Charles University, Prague, and Motol and Homolka University Hospital, Czech Republic
STUDY_CHAIRVáclav Dvořáček, PhD
Czech Agrifood Research Center, Prague, Czech Republic
Outcome results
None listed