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Clinical Trials/NCT01756963
NCT01756963
Completed
Not Applicable

Diet and Disease Activity in Patients With Inflammatory Bowel Disease

Maastricht University Medical Center1 site in 1 country273 target enrollmentNovember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammatory Bowel Disease
Sponsor
Maastricht University Medical Center
Enrollment
273
Locations
1
Primary Endpoint
The primary aim is to study the association of dietary patterns with disease activity in a consecutive cohort of IBD outpatients
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
July 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

The primary aim is to study the association of dietary patterns with disease activity in a consecutive cohort of IBD outpatients

Time Frame: 2 years

Secondary Outcomes

  • To characterize intestinal microbiota in IBD patients with different dietary patterns(2 years)
  • To characterize the intestinal microbiota in IBD patients in remission developing an exacerbation during follow up(2 years)
  • To investigate the stability of the intestinal microbiota in IBD patients remaining in remission during one year follow-up(2 years)
  • To study the prevalence of malnutrition in a consecutive cohort of IBD outpatients(1 year)
  • The study the association of disease characteristics and dietary intake with the prevalence of malnutrition in a consecutive cohort of IBD outpatients(1 year)
  • To study the sensitivity and specificity of the SNAQ / MST as malnutrition screening tool in IBD outpatients based(1 year)

Study Sites (1)

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