Trials Sponsors Conditions Drugs Pricing

Conditions

Celiac Disease

Keywords

aveninsceliac diseasegluten-free dietoatinterleukin-8intestinal fatty acid binding protein

Outcome Measures

Primary Outcomes (7)

Change in EMA-IgA
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
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
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
Change in high-sensitivity C-reactive protein (hs-CRP, mg/L) levels as a marker of systemic inflammation.

Study Arms (1)

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.

Dietary Supplement: certified gluten-free oats of the Saul variety

Interventions

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

adults with celiac disease in who adhered to a strict gluten-free diet

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Faculty Hospital Kralovske Vinohrady
Governmentlead

Study Sites (1)

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

Prague, 10034, Czechia

Related Publications (1)

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.
PMID: 35206043BACKGROUND

MeSH Terms

Conditions

Celiac DiseaseGyrate Atrophy

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesEye Diseases, HereditaryEye DiseasesChoroid DiseasesUveal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

Iva Hoffmanová, MD,PhD
Department of Internal Medicine, Second Faculty of Medicine, Charles University, Prague, and Motol and Homolka University Hospital, Czech Republic
PRINCIPAL INVESTIGATOR
Václav Dvořáček, PhD
Czech Agrifood Research Center, Prague, Czech Republic
STUDY CHAIR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: associate professor MUDr. Iva Hoffmanová, Ph.D.

Study Record Dates

First Submitted

March 20, 2026

First Posted

April 7, 2026

Study Start

January 7, 2022

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (7)

Study Arms (1)

adults with celiac disease in who adhered to a strict gluten-free diet

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (7)

Study Arms (1)

adults with celiac disease in who adhered to a strict gluten-free diet

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations