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Intervention: FC measurements with IBDoc for Ulcerative Colitis

N/A
Waitlist Available
Led By Gregory Rosenfeld, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

Hypothesis: Pro-active home fecal calprotectin testing in patients with Ulcerative Colitis will allow early detection and treatment of inflammation to prevent symptomatic flares. This will result in less steroid use, fewer hospitalizations and a reduced risk of surgery, as well as improved quality of life and adherence to medication.

Eligible Conditions
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The time to a symptomatic flare, defined as an increase in modified partial Mayo score > 2 points from baseline or a rectal bleeding score > 1
Secondary outcome measures
Correlation of fecal calprotectin with endoscopic activity
Correlation of fecal calprotectin with histologic disease activity
Hospitalization, surgery, steroid or biologic use
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intervention: FC measurements with IBDocExperimental Treatment1 Intervention
Fecal Calprotectin (FC) measurements with IBDocTM home kits will be performed by participants in the intervention group every 2 months until final visit. Basic research data will be collected and participants in this group will be asked to complete the on-line questionnaires (SIBDQ and EQ-5D 5L) on baseline visit and month 6, 12 and month 18.
Group II: ControlExperimental Treatment0 Interventions
The group will receive current standard of care as the usual practice of the attending physician. Basic research data will be collected and participants in this group will be asked to complete the on-line questionnaires (SIBDQ and EQ-5D 5L) on the baseline visit and month 6, 12 and month 18. When endoscopy is performed biopsies should be taken and the endoscopic and histologic assessment will be recorded. If a fecal calprotectin is measured, every effort should be made to use the IBDoc with the result being sent to the central primary investigator via the IBDoc Web Portal. However, should a different fecal calprotectin measure be used, this will be recorded as part of the study documentation and will be included in the study data.

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Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,451 Previous Clinical Trials
2,482,464 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
1,306 Patients Enrolled for Ulcerative Colitis
Gregory Rosenfeld, MDPrincipal InvestigatorUniversity of British Columbia, Depart. of Medicine, Div. of Gastroenterology
~30 spots leftby Dec 2024
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