NCT01405105

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 14, 2014

Status Verified

February 1, 2014

Enrollment Period

2.8 years

First QC Date

July 28, 2011

Last Update Submit

February 13, 2014

Conditions

Ulcerative ColitisCrohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Frequency of identifiable trigger for flare

    baseline

Study Arms (2)

Patients with Flares of IBD

Active flare of Crohn's or UC

Control Group

Patients with quiescent Crohn's disease or UC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • History of verified Crohn's disease or ulcerative colitis

You may not qualify if:

  • unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Colitis, UlcerativeCrohn Disease

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Linda A Feagins, MD

    Dallas VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Gastroenterologist

Study Record Dates

First Submitted

July 28, 2011

First Posted

July 29, 2011

Study Start

August 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 14, 2014

Record last verified: 2014-02

Locations

US(1)