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Diet and Disease Activity in Patients With Inflammatory Bowel Disease
This study is currently recruiting participants.
Verified December 2016 by Maastricht University Medical Center
Sponsor:
Maastricht University Medical Center
Collaborator:
Wageningen University
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01756963
First received: December 20, 2012
Last updated: December 14, 2016
Last verified: December 2016
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Purpose
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 |
|---|
| Inflammatory Bowel Disease |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration: | 1 Year |
| Official Title: | Diet and Disease Activity in Patients With Inflammatory Bowel Disease |
Further study details as provided by Maastricht University Medical Center:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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 ]
| Estimated Enrollment: | 600 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| IBD-SL cohort |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Consecutive IBD patients, visiting the gastroenterology outpatient clinic, participating the IBD-SL cohort
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01756963
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756963
Contacts
| Contact: Corinne Spooren, MD | 0031 43381982 | c.spooren@maastrichtuniversity.nl |
Locations
| Netherlands | |
| Maastricht University Medical Center, Division of Gastroenterology/Hepatology | Recruiting |
| Maastricht, Limburg, Netherlands | |
| Contact: Corinne Spooren, MD +31433881982 c.spooren@maastrichtuniversity.nl | |
Sponsors and Collaborators
Maastricht University Medical Center
Wageningen University
Investigators
| Principal Investigator: | M. Pierik, MD. PhD. | Maastricht University Medical Center |
More Information
| Responsible Party: | Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01756963 History of Changes |
| Other Study ID Numbers: |
NL 42101.068.12 |
| Study First Received: | December 20, 2012 |
| Last Updated: | December 14, 2016 |
Additional relevant MeSH terms:
|
Intestinal Diseases Inflammatory Bowel Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |
ClinicalTrials.gov processed this record on June 26, 2017