Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| QK1810102 | Other Grant/Funding Number | Ministry of Agriculture of the Czech Republic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment) |
| Change in PRSQ score |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, University Hospital Kralovske Vinohrady, Prague, Czech Republic | Prague | 10034 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35206043 | Background | 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. |
Not provided
Not provided
Anonymized data will be included as supplementary material in the published article.
Not provided
IPD and supporting information will not be publicly available. Anonymized data are included in the supplementary material of the published study.
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| D015799 | Gyrate Atrophy |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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) |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |