Cytokines and Genes in Therapeutic Response in Crohn's Disease

Vanderbilt University Medical Center

Status: Completed

Conditions: Inflammatory Bowel Diseases

Treatments: Other: Crohn's disease activity index (CDAI); Diagnostic Test: Post treatment blood sample; Diagnostic Test: Baseline stool sample; Diagnostic Test: Post treatment stool sample; Diagnostic Test: Post treatment intestinal biopsies; Diagnostic Test: Baseline intestinal biopsies; Diagnostic Test: Baseline blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT03266471

171198

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients that are seen in the Inflammatory Bowel Disease clinic with Crohn's disease who are initiating either treatment as part of their routine clinical care.
• Healthy adults without IBD undergoing colonoscopy for colorectal cancer screening or other non-IBD related indication.

Exclusion criteria

• pregnant
• have a known coagulopathy or bleeding disorder
• have known renal or hepatic impairment
• have a history of organ transplantation
• CD patients who are being seen in consultation and do not plan to receive longitudinal care through initiation their new therapy at the Vanderbilt IBD center will be excluded.

Trial design

96 participants in 2 patient groups

Crohn's disease Patients

Description:

Patients that are seen in the Inflammatory Bowel Disease clinic with CD confirmed by endoscopy or radiology assessment who are initiating either an anti-tumor necrosis factor (TNF)-α agent (infliximab, adalimumab, certolizumab, or infliximab biosimilar), ustekinumab, or vedolizumab as part of their routine clinical care will be asked to provide blood samples, stool samples, and intestinal biopsies from standard of care colonoscopy at baseline and post therapy of at least 6 weeks duration but not more than 52 weeks.

Treatment:

Other: Crohn's disease activity index (CDAI)

Diagnostic Test: Post treatment stool sample

Diagnostic Test: Baseline stool sample

Diagnostic Test: Post treatment blood sample

Diagnostic Test: Baseline blood sample

Diagnostic Test: Baseline intestinal biopsies

Diagnostic Test: Post treatment intestinal biopsies

Controls

Description:

Healthy adults without IBD undergoing colonoscopy for colorectal cancer screening or other non-IBD related indication will be asked to provide blood samples, stool samples and intestinal biopsies from standard of care colonoscopy.

Treatment:

Diagnostic Test: Baseline stool sample

Diagnostic Test: Baseline blood sample

Diagnostic Test: Baseline intestinal biopsies