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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014