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Exacerbating Factors in Inflammatory Bowel Disease

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.
ClinicalTrials.gov Identifier: NCT01405105
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : February 14, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
Cross-sectional study of potential triggers for flares of Crohn's disease or ulcerative colitis.

Condition or disease
Ulcerative Colitis Crohn's Disease

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.

Study Design

Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Exacerbating Factors in Inflammatory Bowel Disease
Study Start Date : August 2009
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Groups and Cohorts

Patients with Flares of IBD
Active flare of Crohn's or UC
Control Group
Patients with quiescent Crohn's disease or UC

Outcome Measures

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

Eligibility Criteria

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)

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

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.
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 Posted: July 29, 2011    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014

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