The pilot 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…
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
gluten free diet from 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 overview of the average number and
severity of GI complaints; 5. Feasibility of the study procedure in preparation
of a larger study.
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 this 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 a first
step we would like to test this approach in a pilot study.
Study objective
The pilot 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 gluten free diet and 3) To explore
whether the level of gluten intake is related to the number and severity of
gastrointestinal (GI) complaints.
Study design
A cross-sectional pilot study. Celiac patients will be made aware of the
possibility to participate in the study by the gastroenterology department of
hospital de Gelderse Vallei, Ede.
At baseline participants receive a questionnaire to obtain information about
general characteristics, their adherence to the gluten free diet, perceived
degree of gluten sensitivity and self-efficacy toward a gluten free diet.
Participants will keep a detailed food record and collect duplicate portions of
all food products and meals 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 gluten free
diet. 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
costs will be reimbursed. In total participants will receive ¤60 for
participation in the pilot 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 knowledge regarding their illness.
Bomenweg 2 15
Wageningen 6703 HD
NL
Bomenweg 2 15
Wageningen 6703 HD
NL
Listed location countries
Age
Inclusion criteria
* Age from 25 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
Exclusion criteria
* Having any co-morbidity
*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 | NL51472.081.14 |