Diet and Disease Activity in Patients With Inflammatory Bowel Disease
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|ClinicalTrials.gov Identifier: NCT01756963|
Recruitment Status : Recruiting
First Posted : December 28, 2012
Last Update Posted : December 15, 2016
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.
|Condition or disease|
|Inflammatory Bowel Disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||600 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Diet and Disease Activity in Patients With Inflammatory Bowel Disease|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
- 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 ]
- To characterize intestinal microbiota in IBD patients with different dietary patterns [ Time Frame: 2 years ]
- To characterize the intestinal microbiota in IBD patients in remission developing an exacerbation during follow up [ Time Frame: 2 years ]
- To investigate the stability of the intestinal microbiota in IBD patients remaining in remission during one year follow-up [ Time Frame: 2 years ]
- To study the prevalence of malnutrition in a consecutive cohort of IBD outpatients [ Time Frame: 1 year ]In a subpopulation of the present cohort (n=300) the nutritional status will be investigated
- The study the association of disease characteristics and dietary intake with the prevalence of malnutrition in a consecutive cohort of IBD outpatients [ Time Frame: 1 year ]
- To study the sensitivity and specificity of the SNAQ / MST as malnutrition screening tool in IBD outpatients based [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756963
|Contact: Corinne Spooren, MD||0031 firstname.lastname@example.org|
|Maastricht University Medical Center, Division of Gastroenterology/Hepatology||Recruiting|
|Maastricht, Limburg, Netherlands|
|Contact: Corinne Spooren, MD +31433881982 email@example.com|
|Principal Investigator:||M. Pierik, MD. PhD.||Maastricht University Medical Center|