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

March 31, 2026 updated by: Iva Hoffmanová, Faculty Hospital Kralovske Vinohrady

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 10034
        • Department of Internal Medicine, University Hospital Kralovske Vinohrady, Prague, Czech Republic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: adults with celiac disease in who adhered to a strict gluten-free diet
Adult participants with celiac disease who are in clinical and immunological remission and have met all inclusion criteria. This arm evaluates the tolerance of gluten-free oats in the form of oat flakes, which participants consume daily for 14 consecutive days, with monitoring for clinical, immunological, and safety outcomes.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)
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.
Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)
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..
Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)
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.
Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)
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.
Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)
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.
Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)
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)
Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty Hospital Kralovske Vinohrady

Investigators

  • Principal Investigator: Iva Hoffmanová, MD,PhD, Department of Internal Medicine, Second Faculty of Medicine, Charles University, Prague, and Motol and Homolka University Hospital, Czech Republic
  • Study Chair: Václav Dvořáček, PhD, Czech Agrifood Research Center, Prague, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2022

Primary Completion (Actual)

February 25, 2022

Study Completion (Actual)

November 20, 2022

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-VP/53/0/2021
  • QK1810102 (Other Grant/Funding Number: Ministry of Agriculture of the Czech Republic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data will be included as supplementary material in the published article.

IPD Sharing Time Frame

IPD and supporting information will not be publicly available. Anonymized data are included in the supplementary material of the published study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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