Diet and Disease Activity in Patients With Inflammatory Bowel Disease
1 other identifier
observational
273
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 20, 2012
CompletedFirst Posted
Study publicly available on registry
December 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedFebruary 5, 2019
February 1, 2019
5.7 years
December 20, 2012
February 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The primary aim is to study the association of dietary patterns with disease activity in a consecutive cohort of IBD outpatients
2 years
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (1)
IBD-SL cohort
Eligibility Criteria
Consecutive IBD patients, visiting the gastroenterology outpatient clinic, participating the IBD-SL cohort
You may qualify if:
- IBD patients, diagnosis based on clinical, endoscopic, histological and/or radiological criteria
- participating IBD-SL cohort
You may not qualify if:
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Wageningen Universitycollaborator
Study Sites (1)
Maastricht University Medical Center, Division of Gastroenterology/Hepatology
Maastricht, Limburg, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
M. Pierik, MD. PhD.
Maastricht University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2012
First Posted
December 28, 2012
Study Start
November 1, 2012
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
February 5, 2019
Record last verified: 2019-02