The study has three main objectives: 1) To determine the exposure to gluten in celiac patients on a gluten free diet and the variance within this exposure, 2) to determine the gluten content of gluten free-labelled products commonly used by celiac…
ID
Source
Brief title
Condition
- Food intolerance syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The endpoints of the study are 1) an overview of commonly used products in a
GFD form the detailed food records and duplicate portions, 2) identification of
products that are perceived to be gluten free but in reality still contain
gluten, 3) determination of the amount of gluten present in these products and
in the total diet, 4) an indicative overview of the average number and severity
of GI complaints, and 5) analysis of the results for a scientific publication
and report .
Secondary outcome
not applicable
Background summary
Diet therapy is the only treatment of celiac disease (CD). It requires
life-long adherence to a gluten-free diet (GFD). The elimination of gluten from
the diet usually leads to fast alleviation of clinical symptoms, although
recovery of the intestinal mucosa can take months or even years. However, a GFD
fails to alleviate symptoms in 7 to 30% of patients. Excluding all non-food
related explanations, it is hypothesised that is due to unintended gluten
exposure in the diet of celiac patients. The most accurate way to test this
hypothesis is by analysing duplicate portions of the diet on gluten. As as
first step we have tested this approach in a pilot study in nine patients. In
this proposed study we expand the number of patients with 25 such to reach an
observation study of good quality (due to more observations).
Study objective
The study has three main objectives: 1) To determine the exposure to gluten in
celiac patients on a gluten free diet and the variance within this exposure, 2)
to determine the gluten content of gluten free-labelled products commonly used
by celiac patients on a GFD and 3) to explore whether the level of gluten
intake is related to the number and severity of gastointestinal (GI) complaints
Study design
A cross-sectional observational study. Celiac patients present in the
electronic patient database of the gastroenterology department of hospital De
Gelderse Vallei, Ede, Canisius-Wilhelmina Ziekenhuis, Nijmegen and Rijnstate,
Arnhem, will receive an invitation letter and information brochure. They will
be pre-selected on basis of the in- and exclusion criteria mentioned below. At
baseline participants receive a questionnaire to obtain information about
general characteristics, their adherence to the GFD, perceived degree of gluten
sensitivity and self-efficacy toward a GFD. Participants will keep a detailed
food record and collect duplicate portions of all food products and mixed
dishes consumed for two days.
Study burden and risks
Participants are asked to fill out a questionnaire about their general health,
GI complaints, perceived gluten sensitivity and adherence to a GFD. In
addition, participants are asked to keep a detailed food record and collect
duplicate portions of all food products used for two days for which costst will
be reimbursed. In total participants will receive 60 E for participation in the
study. The study is non-invasive, however, keeping the food records and
duplicate portion collection can be perceived as burdensome and time consuming.
There are no risks associated with participation due to its observatory nature.
Benefits for the individual participants are that they receive detailed
information about the gluten content of their diet and that they contribute to
advancement of knowlegde regarding their illness.
Akkermaalsbos 2
Wageningen 6708 WB
NL
Akkermaalsbos 2
Wageningen 6708 WB
NL
Listed location countries
Age
Inclusion criteria
Age from 18 to 65 years at the time of recruitment
confirmed diagnosis of celiac disease through intestinal biopsy
adherence to a gluten-free diet for at least 1 year
anti-tTG measurements available in medical records (max 1 year old)
Exclusion criteria
having any co-morbidity; diabetes mellitus type 1, microscopic colitis, thyroid diseases
unable or unwilling to comply with the study procedures
wittingly consuming gluten
having exacerbation of GI complaints
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 | NL60157.081.16 |