96
Participants
Start Date
October 13, 2017
Primary Completion Date
May 3, 2022
Study Completion Date
May 3, 2022
Baseline blood sample
Blood sample for cytokine measurements and genetics.
Baseline intestinal biopsies
Up to 20 additional biopsies will be obtained at the time of standard of care colonoscopy. It is not felt that additional biopsies substantially increases the risk of a colonoscopy. Cytokine measurements will be performed on the tissue collected.
Crohn's disease activity index (CDAI)
To determine response, a Crohn's Disease Activity Index (CDAI) score will be obtained at time point 1 and time point 2 in all enrolled CD patients. The CDAI is a well validated symptom index for CD which assesses 8 factors including stool frequency, abdominal pain, general well being, CD complications, HCT, and deviation from ideal body weight.
Post treatment blood sample
Blood sample for cytokine measurements after patients have been on therapy for at least 6 weeks but no more than 52 weeks.
Post treatment intestinal biopsies
Up to 20 additional biopsies will be obtained at the time of standard of care colonoscopy at least 6 weeks but no more than 52 weeks after initiation of therapy. It is not felt that additional biopsies substantially increases the risk of a colonoscopy. Cytokine measurements will be performed on the tissue collected.
Baseline stool sample
Stool sample for inflammatory markers or microbiome analysis.
Post treatment stool sample
Stool sample for inflammatory markers or microbiome analysis.
Inflammatory Bowel Disease Clinic, Vanderbilt University Medical Center, Nashville
Vanderbilt University Medical Center Endoscopy Laboratory, Nashville
Vanderbilt University Medical Center
OTHER