Exacerbating Factors in Inflammatory Bowel Disease

This study has been completed.
Sponsor:
Collaborator:
Centocor Ortho Biotech Services, L.L.C.
Information provided by (Responsible Party):
Linda A Feagins, Dallas VA Medical Center
ClinicalTrials.gov Identifier:
NCT01405105
First received: July 28, 2011
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

Cross-sectional study of potential triggers for flares of Crohn's disease or ulcerative colitis.


Condition
Ulcerative Colitis
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Exacerbating Factors in Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Dallas VA Medical Center:

Primary Outcome Measures:
  • Frequency of identifiable trigger for flare [ Time Frame: baseline ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: August 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Flares of IBD
Active flare of Crohn's or UC
Control Group
Patients with quiescent Crohn's disease or UC

Detailed Description:

Detailed questionnaires with patient in regards to potential triggers for flares of IBD. Includes both patients with flares and those in remission as a control group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Flare of Crohn's disease Flare of ulcerative colitis Quiescent IBD (control)

Criteria

Inclusion Criteria:

  • History of verified Crohn's disease or ulcerative colitis

Exclusion Criteria:

  • unwilling to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405105

Locations
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Dallas VA Medical Center
Centocor Ortho Biotech Services, L.L.C.
Investigators
Principal Investigator: Linda A Feagins, MD Dallas VA Medical Center
  More Information

No publications provided

Responsible Party: Linda A Feagins, Staff Gastroenterologist, Dallas VA Medical Center
ClinicalTrials.gov Identifier: NCT01405105     History of Changes
Other Study ID Numbers: DVAMC-09-010
Study First Received: July 28, 2011
Last Updated: February 13, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 20, 2014