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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
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
Department of Internal Medicine, University Hospital Kralovske Vinohrady, Prague, Czech Republic
Prague, Czechia
Change in EMA-IgA
Change in endomysial antibody IgA (EMA-IgA) titers as a marker of celiac disease activity.
Time frame: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)
Change in tTG-IgA
Change in tissue transglutaminase IgA (tTG-IgA, U/mL) levels as a marker of celiac disease activity.
Time frame: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)
Change in DGP-IgG
Change in deamidated gliadin peptide IgG (DGP-IgG, U/mL) levels as a marker of celiac disease activity..
Time frame: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)
Change in hs-CRP
Change in high-sensitivity C-reactive protein (hs-CRP, mg/L) levels as a marker of systemic inflammation.
Time frame: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)
Change in I-FABP
Change in intestinal fatty acid-binding protein (I-FABP, ng/mL) levels as a marker of enterocyte damage.
Time frame: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)
Change in IL-8
Change in interleukin-8 (IL-8, pg/mL) levels as a marker of mucosal immune activation.
Time frame: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)
Change in PRSQ score
Change in patient-reported gastrointestinal and extraintestinal symptoms score (PRSQ, range 0-150; higher scores indicate greater symptom burden)
Time frame: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.