Diet and Disease Activity in Patients With Inflammatory B... | NCT01756963

Studies
Diet and Disease Activity in Patients With Inflammatory Bowel Disease

NCT01756963

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Feb 5, 2019Actual

Enrollment

273Actual

Phase

Not provided

Conditions

Inflammatory Bowel Disease

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jul 2018Actual

Completion Date

Jul 2018Actual

First Submitted Date

Dec 20, 2012

First Submission Date that Met QC Criteria

Dec 20, 2012

First Posted Date

Dec 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2019

Last Update Posted Date

Feb 5, 2019Actual

Name	Class
Wageningen University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

273Actual

Label	Type	Description	Intervention Names
IBD-SL cohort

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
M. Pierik, MD. PhD.	Maastricht University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Center, Division of Gastroenterology/Hepatology		Maastricht	Limburg		Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided