Celiac DiseaseGFOATSAULNCT07515105
Gluten Free Oat (Cultivar Saul) in Celiac Disease in Remission
A study testing certified gluten-free oats of the Saul variety in people with Celiac Disease, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease
- What is being tested?
- certified gluten-free oats of the Saul variety
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 7 Jan 2022to 20 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Internal Medicine, University Hospital Kralovske Vinohrady, Prague, Czech Republic
Prague, 10034
About this study
Official title: 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.
Read the 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.
- 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).
- Conditions
- Celiac Disease
- Being tested
- certified gluten-free oats of the Saul variety
- Keywords
- avenins, celiac disease, gluten-free diet, oat, interleukin-8, intestinal fatty acid binding protein
- Medical subject headings
- Celiac Disease, Gyrate Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
certified gluten-free oats of the Saul varietyDietary 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
| Study group | Role | What they receive |
|---|---|---|
| adults with celiac disease in who adhered to a strict gluten-free diet | Experimental | 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. Receives: Dietary Supplement: certified gluten-free oats of the Saul variety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EMA-IgA
Change in endomysial antibody IgA (EMA-IgA) titers as a marker of celiac disease activity.
Measured: 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.
Measured: 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..
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start7 Jan 2022
- Primary completion25 Feb 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Iva Hoffmanová, Faculty Hospital Kralovske Vinohrady
- Investigators
- Iva Hoffmanová, MD,PhD, Principal investigator, Department of Internal Medicine, Second Faculty of Medicine, Charles University, Prague, and Motol and Homolka University Hospital, Czech RepublicVáclav Dvořáček, PhD, Study chair, Czech Agrifood Research Center, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515105
- Sponsor's protocol ID
- EK-VP/53/0/2021
- Other IDs
- QK1810102
- Acronym
- GFOATSAUL
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be included as supplementary material in the published article.
Publications
Dvoracek V, Kotrbova-Kozak A, Kozova-Dolezalova J, Jagr M, Hlasna Cepkova P, Vitamvas P, Kosova K. Specific Avenin Cross-Reactivity with G12 Antibody in a Wide Range of Current Oat Cultivars. Foods. 2022 Feb 16;11(4):567. doi: 10.3390/foods11040567.
PubMed 35206043
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of a Low-immunogenic Oat Cultivar (Saul) in Adults With Celiac Disease in Remission: a Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT07515105
- Acronym / sponsor ID
- GFOATSAUL / EK-VP/53/0/2021
- Conditions
- Celiac Disease
- Keywords
- avenins, celiac disease, gluten-free diet, oat, interleukin-8, intestinal fatty acid binding protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adults with celiac disease in who adhered to a strict gluten-free diet | Experimental | Dietary Supplement: certified gluten-free oats of the Saul varietyAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| certified gluten-free oats of the Saul varietyVariability 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 | Dietary supplement | adults with celiac disease in who adhered to a strict gluten-free diet |
Primary outcome
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.
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.
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..
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.
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.
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 35206043Dvoracek V, Kotrbova-Kozak A, Kozova-Dolezalova J, Jagr M, Hlasna Cepkova P, Vitamvas P, Kosova K. Specific Avenin Cross-Reactivity with G12 Antibody in a Wide Range of Current Oat Cultivars. Foods. 2022 Feb 16;11(4):567. doi: 10.3390/foods11040567.
- Individual participant dataSharing planned: Yes. Anonymized data will be included as supplementary material in the published article.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iva Hoffmanová, MD,PhD principal investigator
Department of Internal Medicine, Second Faculty of Medicine, Charles University, Prague, and Motol and Homolka University Hospital, Czech Republic
Václav Dvořáček, PhD study chair
Czech Agrifood Research Center, Prague, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing certified gluten-free oats of the Saul variety in people with Celiac Disease, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EMA-IgA (time frame: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07515105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.