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

Correlation between symptoms and the presence of gluten immunogenic peptides in faeces and urine after single dose gluten provocation in patients with coeliac disease* - Gluten intake, symptoms and detection of gluten in urine and feces

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43024
Enrollment
40
Registered
2018-07-10
Start date
2018-12-14
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac disease

Interventions

During a 12 week period, both groups will take capsules on 6 time points containing either gluten (3 times) or placebo (rice-starch) (3 times) with a 2 week washout period

Sponsors

Rijnstate Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The correlation between the presence of GIP in urine/ faeces and symptoms after gluten provocation

Secondary

MeasureTime frame
None

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)