Clinical trial NCT01756963: Diet and Disease Activity in Patients With Inflammatory Bowel Disease
Official title: Diet and Disease Activity in Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Wageningen University
First posted: 2012-12-28
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive IBD patients, visiting the gastroenterology outpatient clinic, participating the IBD-SL cohort

Brief 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.

The investigators hypothesize that differences in dietary patterns affects the intestinal microbiota composition and thereby contributes to the development of exacerbations in IBD.

Furthermore, a subgroup of patients suffers from malnutrition, although the exact prevalence is unknown since simple noninvasive screening tools have not been validated for IBD. The investigators hypothesize that malnutrition is frequently present in IBD patients and associated with dietary intake and disease characteristics.


Eligibility criteria: Inclusion Criteria:

* IBD patients, diagnosis based on clinical, endoscopic, histological and/or radiological criteria
* participating IBD-SL cohort

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: The primary aim is to study the association of dietary patterns with disease activity in a consecutive cohort of IBD outpatients
timeFrame: 2 years
Secondary outcomes:
measure: To characterize intestinal microbiota in IBD patients with different dietary patterns
timeFrame: 2 years
measure: To characterize the intestinal microbiota in IBD patients in remission developing an exacerbation during follow up
timeFrame: 2 years
measure: To investigate the stability of the intestinal microbiota in IBD patients remaining in remission during one year follow-up
timeFrame: 2 years
measure: To study the prevalence of malnutrition in a consecutive cohort of IBD outpatients
timeFrame: 1 year
measure: The study the association of disease characteristics and dietary intake with the prevalence of malnutrition in a consecutive cohort of IBD outpatients
timeFrame: 1 year
measure: To study the sensitivity and specificity of the SNAQ / MST as malnutrition screening tool in IBD outpatients based
timeFrame: 1 year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center, Division of Gastroenterology/Hepatology
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: M. Pierik, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: