CompletedNot Applicable

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

Czechia40 participantsStarted 2022-01-07

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in EMA-IgA

Timeframe: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)

Change in tTG-IgA

Timeframe: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)

Change in DGP-IgG

Timeframe: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)

Change in hs-CRP

Timeframe: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)

Change in I-FABP

Timeframe: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)

Change in IL-8

Timeframe: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)

Change in PRSQ score

Timeframe: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)

Trial details

NCT IDNCT07515105

SponsorFaculty Hospital Kralovske Vinohrady

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-02-25

View on ClinicalTrials.gov More Celiac Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in EMA-IgA

Timeframe: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)

Change in tTG-IgA

Timeframe: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)

Change in DGP-IgG

Timeframe: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)

Change in hs-CRP

Timeframe: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)

Change in I-FABP

Timeframe: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)

Change in IL-8

Timeframe: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)

Change in PRSQ score

Timeframe: Day 1 (Baseline, start of oat consumption) and Day 15 (Post-intervention assessment)