To assess the correlation between the presence of GIP in urine/ faeces and symptoms after a single dose gluten provocation (mimicking the daily risk of gluten ingestion) in patients with coeliac disease adhering to a strict gluten-free diet.
ID
Source
Brief title
Condition
- Malabsorption conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The correlation between the presence of GIP in urine/ faeces and symptoms after
gluten provocation
Secondary outcome
None
Background summary
Up to 20 percent of coeliac patients continue to experience symptoms despite
reporting strict adherence to gluten-free diet. Persistent symptoms may be
related to cryptogenic gluten intake. Recent studies found gluten immunogenic
peptides (GIP) in feces of 30 percent of patients reporting strict adherence.
Study objective
To assess the correlation between the presence of GIP in urine/ faeces and
symptoms after a single dose gluten provocation (mimicking the daily risk of
gluten ingestion) in patients with coeliac disease adhering to a strict
gluten-free diet.
Study design
prospective, single blind, placebo controlled cross-over trial
Intervention
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
Study burden and risks
The risks mimic daily life risk of cryptogenic gluten ingestion which can cause
temporary coeliac symptoms such as bloating, abdominal distress and diarrhea.
Patient only need to visit ones to discuss study participation. No blood
samples will be taken. Patients have to collect 7 urine and feces samples which
will be collected at their homes by a trial nurse. Patients have to fill in
short forms addressing coeliac complaints and dietary issues.
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59453.091.16 |