Correlation between symptoms and the presence of gluten immunogenic peptides in faeces and urine after single dose gluten provocation in patients with coeliac disease*

Recruiting

• Conditions: Celiac disease; 10025477

• Registration Number: NL-OMON43024
• Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Patients with biopsy proven coeliac disease, Marsh IIIA or higher at time of diagnosis, adhering to a gluten-free diet and aged 18 years or older are eligible if:

- They report clear symptoms on gluten exposure
- They report excellent or no problems with dietary adherence (score 13 or less) on the Celiac Disease Adherence Test (CDAT)(8) (Appendix 2)
- They report scores resembling clinical remission (score 30 or less) on the Celiac Symptom Index (CSI)(9) (Appendix 3)
- Serum TTG and EMA levels are non-detectable during gluten-free diet
- Negative GIP in urine/ faeces at the start of this study

Exclusion Criteria

Patients will be excluded if;
- They report other CDAT and/or CSI scores
- They are pregnant
- They have known gastroenterological co-morbidity
- They have malignant disease
- They use painkillers or other drugs to reduce symptoms

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The correlation between the presence of GIP in urine/ faeces and symptoms after<br /><br>gluten provocation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>None</p><br>