Diet and Disease Activity in Patients With Inflammatory Bowel Disease

Completed

• Conditions: Inflammatory Bowel Disease

• Registration Number: NCT01756963
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-28
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-04
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim is to study the association of dietary patterns with disease activity in a consecutive cohort of IBD outpatients	2 years

Secondary Outcome Measures

Name	Time	Method
To characterize intestinal microbiota in IBD patients with different dietary patterns	2 years
To characterize the intestinal microbiota in IBD patients in remission developing an exacerbation during follow up	2 years
To investigate the stability of the intestinal microbiota in IBD patients remaining in remission during one year follow-up	2 years
To study the prevalence of malnutrition in a consecutive cohort of IBD outpatients	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	1 year
To study the sensitivity and specificity of the SNAQ / MST as malnutrition screening tool in IBD outpatients based	1 year

Trial Locations

Locations (1)

Maastricht University Medical Center, Division of Gastroenterology/Hepatology; 🇳🇱 Maastricht, Limburg, Netherlands