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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:
ClinicalTrials.gov Identifier:
NCT01756963
First Posted: December 28, 2012
Last Update Posted: December 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Wageningen University
Information provided by (Responsible Party):
Maastricht University Medical Center
  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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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


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
First Submitted: December 20, 2012
First Posted: December 28, 2012
Last Update Posted: December 15, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis


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