Diet and Disease Activity in Patients With Inflammatory Bowel Disease

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease

• Study Type: Observational
• Enrollment (Actual): 273

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands
      • Maastricht University Medical Center, Division of Gastroenterology/Hepatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive IBD patients, visiting the gastroenterology outpatient clinic, participating the IBD-SL cohort

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
IBD-SL cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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	In a subpopulation of the present cohort (n=300) the nutritional status will be investigated	1 year
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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Wageningen University
• Investigators: Principal Investigator: M. Pierik, MD. PhD., Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: December 20, 2012
• First Posted (Estimate): December 28, 2012

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: NL 42101.068.12