- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01405105
Exacerbating Factors in Inflammatory Bowel Disease
February 13, 2014 updated by: Linda A Feagins, Dallas VA Medical Center
Cross-sectional study of potential triggers for flares of Crohn's disease or ulcerative colitis.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
134
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Dallas, Texas, United States, 75216
- Dallas VA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Flare of Crohn's disease Flare of ulcerative colitis Quiescent IBD (control)
Description
Inclusion Criteria:
- History of verified Crohn's disease or ulcerative colitis
Exclusion Criteria:
- unwilling to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
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Patients with Flares of IBD
Active flare of Crohn's or UC
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|
Control Group
Patients with quiescent Crohn's disease or UC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Frequency of identifiable trigger for flare
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Linda A Feagins, MD, Dallas VA Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
July 28, 2011
First Submitted That Met QC Criteria
July 28, 2011
First Posted (Estimate)
July 29, 2011
Study Record Updates
Last Update Posted (Estimate)
February 14, 2014
Last Update Submitted That Met QC Criteria
February 13, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DVAMC-09-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Crohn's Disease
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ProgenaBiomeWithdrawnCrohn Disease | Crohn Colitis | Crohn's Ileocolitis | Crohn's Gastritis | Crohn's Jejunitis | Crohn's Duodenitis | Crohn's Esophagitis | Crohn's | Crohn Disease of Ileum | Crohn Ileitis | Crohn's Disease Relapse | Crohns Disease Aggravated | Crohn Disease in Remission | Crohn's Disease of PylorusUnited States
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Sixth Affiliated Hospital, Sun Yat-sen UniversityNot yet recruitingCrohn's Disease Aggravated | Crohn's Disease in Remission
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Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); American...RecruitingInflammatory Bowel Diseases | Crohn Disease | Crohn Colitis | Crohn's Ileocolitis | Crohn's Gastritis | Crohn's Jejunitis | Crohn's Duodenitis | Crohn's EsophagitisUnited States
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Tanabe Pharma CorporationCompleted
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Massachusetts General HospitalRecruitingCrohn's Ileocolitis | Crohn's Gastritis | Crohn's Jejunitis | Crohn's Duodenitis | Crohn's Esophagitis | Inflammatory Bowel Disease (IBD) | Crohn's Colitis | Indeterminate Colitis | Ulcerative Colitis (UC) | Ulcerative Proctitis | Ulcerative Proctosigmoiditis | Crohn's Disease Colon | IBD-unclassified (IBD-U)United States
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Richard Burt, MDTerminatedCROHN'S DISEASEUnited States
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Kate Farms IncUniversity of MinnesotaCompleted
-
Agomab Spain S.L.U.Active, not recruitingFibrostenotic Crohn's DiseaseUnited States, Spain, Denmark, Austria, Poland, Italy, Canada, Germany
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AbbVieCompletedCrohn's Disease (CD)United States, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Romania, Spain, United Kingdom, Poland, Slovakia, Belgium