Not Yet RecruitingNot Applicable

Assessment of the Adherence to a Gluten-free Diet and Nutritional Status of Paediatric Patients With Coeliac Disease

140 participantsStarted 2026-01

Plain-language summary

Although a gluten-free diet (GFD) is essential for patients with coeliac disease (CD), many do not follow it strictly. Exposure to gluten causes villous atrophy, can deteriorate nutritional status, and can lead to deficiencies. The ESPGHAN recommends combining multiple methods to assess GFD adherence. The Celiac Dietary Adherence Test (CDAT) and measuring the gluten immunogenic peptide in urine (uGIP) or stool (sGIP) were suggested. This study aims to evaluate and compare the usefulness of an adapted CDAT, the rapid tests for detecting uGIP and sGIP, for assessing adherence to a GFD in children with CD. Additionally, we will assess these children's nutritional status. Patients, aged 2-18 years, diagnosed with CD, who have been on a GFD for at least 6 months, will be included. Clinical characteristics and anthropometric measurements will be recorded. The adapted CDAT form will be applied. A single urine and stool samples will be collected immediately, and rapid tests for the detection of GIP will be performed. The serum levels of anti-transglutaminase antibodies (IgA), albumin, ferritin, folate, vitamins B12, A, E, 25-OH vitamin D, blood count and lipid profile will be measured.

Who can participate

Age range

2 Years – 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: * diagnosis of coeliac disease according to the European Society of Pediatric Gastroenterology and Nutrition (ESPGHAN) criteria, * age from 2 to 18 years of age, * gluten-free diet use for at least 6 months, * consent from legal guardians (and the child in case of patients ≥16 years of age) to participate in the study. Exclusion criteria: * under 2 years of age and over 18 years of age, * immunoglobulin A deficiency, * inflammatory bowel diseases, * gastrointestinal bleeding or other active bleeding, * gastric and/or duodenal ulcers, * liver failure, * heart failure according to the NYHA II-IV scale, * acute and chronic renal failure, * cancer, * after hematopoietic stem cell transplantation, * whose legal guardians did not consent to participate in the study, * who did not consent to participate in the study (applies to patients ≥ 16 years of age).

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

Adherence to a gluten-free diet - the Celiac Dietary Adherence Test.

Timeframe: January 2026 - June 2027

Adherence to the gluten-free diet - the gluten immunogenic peptide in urine.

Timeframe: January 2026 - June 2027

Adherence to the gluten-free diet - the gluten immunogenic peptide in stool.

Timeframe: January 2026 - June 2027

Comparison of methods

Timeframe: January 2026 - June 2027

Trial details

NCT IDNCT07157137

SponsorMedical University of Warsaw

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06

View on ClinicalTrials.gov More Celiac Disease in Children trials

Plain-language summary

Who can participate

Age range

2 Years – 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

Adherence to a gluten-free diet - the Celiac Dietary Adherence Test.

Timeframe: January 2026 - June 2027

Adherence to the gluten-free diet - the gluten immunogenic peptide in urine.

Timeframe: January 2026 - June 2027

Adherence to the gluten-free diet - the gluten immunogenic peptide in stool.

Timeframe: January 2026 - June 2027

Comparison of methods

Timeframe: January 2026 - June 2027