We aim to study the role of diet in IBD in 2 subprojects: A) to study the prevalence of malnutrition in a consecutive cohort of IBD outpatients and to validate a malnutrition screening tool for IBD; B) To study the association of dietary patterns…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the prevalence of malnutrition in a consecutive
IBD outpatient cohort for part A and the identification of different dietary
patterns in relation to disease activity in IBD for part B.
Secondary outcome
Part A
1.To study the prevalence of vitamin and or mineral deficiencies determined in
blood samples in a consecutive cohort of IBD outpatients.
2.The study the association of disease characteristics and dietary intake with
the prevalence of malnutrition in a consecutive cohort of IBD outpatients
3. To study the sensitivity and specificity of the SNAQ / MST as malnutrition
screening tool in IBD outpatients based.
Part B
1.To characterize intestinal microbiota in IBD patients with different dietary
patterns
2.To characterize the intestinal microbiota in IBD patients in remission
developing an exacerbation during follow up
3.To investigate the stability of the intestinal microbiota in IBD patients
remaining in remission during one year follow-up
4. The role of dietary intake on epigenetics in the development of
exacerbations among IBD patients
Background summary
In addition to a genetic susceptibility, the immune system and the intestinal
microbiota, diet is hypothesized to be an important factor in the onset and
progression of Inflammatory Bowel Diseases (IBD). Further insight in factors
affecting disease activity may contribute to targeted interventions improving
disease burden and healthcare costs for these patients. However, well-designed
studies exploring the role of diet in the development of exacerbations are
hardly available. Furthermore, a subgroup of patients suffers from
malnutrition, although the exact prevalence is unknown since simple
non-invasive screening tools have not been validated for IBD.
Study objective
We aim to study the role of diet in IBD in 2 subprojects: A) to study the
prevalence of malnutrition in a consecutive cohort of IBD outpatients and to
validate a malnutrition screening tool for IBD; B) To study the association of
dietary patterns and intestinal microbiota composition with disease activit,
and possible mechanisme in a consecutive cohort of IBD patients of the IBD-SL
biobank cohort.
Study design
Part A is a cross-sectional cohort study (n=300) and part B is a prospective
cohort study with a follow up of one year (n=600).
Study burden and risks
The population based IBD-SL cohort is an excellent cohort to assess
malnutrition in IBD patients. Blood and fecal samples are taken for routine
clinical care. A part of the fecal sample will be stored in de IBD-SL biobank
cohort for microbiota analyses. One extra serum tube (10 ml) and plasma tube
(8,5 ml) will be collected and stored in the biobank. At baseline
questionnaires have to be completed (Food frequency questionnaire (FFQ), short
nutritional assessment questionnaire (SNAQ), malnutrition screening tool (MST))
which will take about 35 minutes. Furthermore anthropometric measurements and a
Bod Pod® are performed. These investigations take about 20-30 minutes.
No side effects are to be expected from these measurements. However entering
the Bod Pod® may be somewhat claustrophobic to certain subjects, because of the
relative small size of the test chamber. Subjects may experience small pressure
changes on the ears.
Patients are followed during one year. At every routine outpatient visit the
results of blood and fecal samples collected for routine clinical care are
gathered and stored in the IBD-SL biobank cohort. Standardized clinical
activity scores are already registered for routine care by the
gastroenterologist and will be extracted from the electronic patient files. No
side effects are expected from these measurements
P. Debeyeplein 25
Maastricht 6202 AZ
NL
P. Debeyeplein 25
Maastricht 6202 AZ
NL
Listed location countries
Age
Inclusion criteria
1. IBD patients, diagnosis based on clinical, endoscopic, histological and/or radiological criteria
2.18-75 years
3. participating IBD-SL biobank cohort
Exclusion criteria
Unable to provide informed consent
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 | NL42101.068.12 |
Other | protocol wordt op clinicaltrial.gov geregistreerd |