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 range

18 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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)