Diet and Disease Activity in Patients With Inflammatory Bowel Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Maastricht University Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
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: NA
Last verified: December 2012
History: No changes posted
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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 fequently 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To characterize intestinal microbiota in IBD patients with different dietary patterns [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To characterize the intestinal microbiota in IBD patients in remission developing an exacerbation during follow up [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To investigate the stability of the intestinal microbiota in IBD patients remaining in remission during one year follow-up [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To study the prevalence of malnutrition in a consecutive cohort of IBD outpatients [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- To study the sensitivity and specificity of the SNAQ / MST as malnutrition screening tool in IBD outpatients based [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (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) |
| Genders Eligible for Study: | Both |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 20, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Additional relevant MeSH terms:
|
Intestinal Diseases Inflammatory Bowel Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |
ClinicalTrials.gov processed this record on September 23, 2016