NCT07515105

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Faculty Hospital Kralovske Vinohrady · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	certified 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

Timeline

• Start date: 2022-01-07
• Primary completion: 2022-02-25
• Completion: 2022-11-20
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: Czechia