Gluten Free Oat (Cultivar Saul) in Celiac Disease in Remission

Tolerability of a Low-immunogenic Oat Cultivar (Saul) in Adults With Celiac Disease in Remission: a Prospective Interventional Study

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).

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.