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Completed

NCT Number: NCT07515105

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

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.

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Key information

Conditions

Celiac Disease Choroid Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Eye Diseases Eye Diseases, Hereditary Gastrointestinal Diseases Genetic Diseases, Inborn Gyrate Atrophy Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Medicine, University Hospital Kralovske Vinohrady, Prague, Czech Republic

Prague, 10034, Czechia

About this study

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.

  • 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.
  • 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.
  • Clinical evaluation involved the assessment of gastrointestinal and extraintestinal symptoms using the Patient-Reported Symptom Questionnaire (PRSQ).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

certified gluten-free oats of the Saul variety

Dietary Supplement

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

Primary outcomes

  1. Change in EMA-IgA

    Time frame: 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.

  2. Change in tTG-IgA

    Time frame: 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.

  3. Change in DGP-IgG

    Time frame: 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..

  4. Change in hs-CRP

    Time frame: 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.

  5. Change in I-FABP

    Time frame: 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.

  6. Change in IL-8

    Time frame: 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.

  7. Change in PRSQ score

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Faculty Hospital Kralovske Vinohrady

Other Gov

Registry information

Official study title

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

Acronym: GFOATSAUL

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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