Skip to main content
OpenTrials
Completed

NCT Number: NCT01756963

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center, Division of Gastroenterology/Hepatology

Maastricht, Limburg, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. To characterize intestinal microbiota in IBD patients with different dietary patterns

    Time frame: 2 years

  2. To characterize the intestinal microbiota in IBD patients in remission developing an exacerbation during follow up

    Time frame: 2 years

  3. To investigate the stability of the intestinal microbiota in IBD patients remaining in remission during one year follow-up

    Time frame: 2 years

  4. 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

  5. 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

  6. To study the sensitivity and specificity of the SNAQ / MST as malnutrition screening tool in IBD outpatients based

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Wageningen University

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2012
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.