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Exacerbating Factors in Inflammatory Bowel Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01405105
First Posted: July 29, 2011
Last Update Posted: February 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centocor Ortho Biotech Services, L.L.C.
Information provided by (Responsible Party):
Linda A Feagins, Dallas VA Medical Center
  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 Linda A Feagins, Dallas VA Medical Center:

Primary Outcome Measures:
  • Frequency of identifiable trigger for flare [ Time Frame: baseline ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 28, 2011
First Posted: July 29, 2011
Last Update Posted: February 14, 2014
Last Verified: February 2014

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