Cytokines and Genes in Therapeutic Response in Crohn's Disease

Summary

Inflammatory bowel disease (IBD), consisting of two major forms, Crohn's disease (CD) and ulcerative colitis (UC), affects more than 1.6 million people in the United States alone. Though the precise mechanisms underlying the inflammation and immune responses in IBD are still being investigated, various inflammatory mediators, including pro-inflammatory cytokines, and genes have been implicated in the disease process. At present, there are no reliable mechanisms to predict response to individual IBD medications. The investigators seek to evaluate whether inflammatory cytokines change longitudinally during treatment with anti-cytokine agents in both treatment primary responders and primary non-responders. In addition, the investigators will be evaluating the pharmacogenetics of treatment response to these agents.

Conditions

• Inflammatory Bowel Diseases

Interventions

DIAGNOSTIC_TEST

Baseline blood sample

Blood sample for cytokine measurements and genetics.

DIAGNOSTIC_TEST

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.

OTHER

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Baseline stool sample

Stool sample for inflammatory markers or microbiome analysis.

DIAGNOSTIC_TEST

Post treatment stool sample

Stool sample for inflammatory markers or microbiome analysis.

Sponsors & Collaborators

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Elizabeth Scoville, MD · Vanderbilt University Medical Center

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-13

Primary Completion

2022-05-03

Completion

2022-05-03

Countries

• United States

Study Locations