Diet and Disease Activity in Patients With Inflammatory Bowel Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Maastricht University Medical Center
Sponsor:
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
  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

Resource links provided by NLM:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

No publications provided

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:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 18, 2014