Diet and Disease Activity in Patients With Inflammatory Bowel Disease

Inflammatory Bowel Disease Clinical Trial

Official title:

Diet and Disease Activity in Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756963
• Other study ID #: NL 42101.068.12
• Status: Completed
• Start date: November 2012
• Est. completion date: July 2018

Study information

• Verified date: February 2019
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center, Division of Gastroenterology/Hepatology	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary aim is to study the association of dietary patterns with disease activity in a consecutive cohort of IBD outpatients		2 years
Secondary	To characterize intestinal microbiota in IBD patients with different dietary patterns		2 years
Secondary	To characterize the intestinal microbiota in IBD patients in remission developing an exacerbation during follow up		2 years
Secondary	To investigate the stability of the intestinal microbiota in IBD patients remaining in remission during one year follow-up		2 years
Secondary	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
Secondary	The study the association of disease characteristics and dietary intake with the prevalence of malnutrition in a consecutive cohort of IBD outpatients		1 year
Secondary	To study the sensitivity and specificity of the SNAQ / MST as malnutrition screening tool in IBD outpatients based		1 year