Identifying Young Inflammatory Bowel Disease Patients at Risk for Herpes Zoster
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|ClinicalTrials.gov Identifier: NCT03553472|
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : November 28, 2018
|Condition or disease|
|Herpes Zoster Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis|
Inflammatory bowel disease (IBD) is a group of chronic inflammatory disorders of the gastrointestinal tract. A recent national survey from the CDC estimates that the prevalence of IBD in the United States (US) is nearly 3.1 million cases. IBD is often associated with debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures and/or surgery. Treatment options include immunosuppressive therapies, such as corticosteroids, immunomodulators (thiopurines and methotrexate) and anti-tumor necrosis factor alpha (TNF) agents. Although they are effective in achieving clinical remission and decrease the risk of complications, they also increase the risk for serious infections, including herpes zoster (HZ).
The primary goal is to study those patients with IBD who are thought to be at the highest risk for HZ reactivation by evaluating cell mediated immunity (CMI) to VZV.
|Study Type :||Observational|
|Estimated Enrollment :||96 participants|
|Official Title:||Identify Young Immunosuppressed and Non-immunosuppressed Inflammatory Bowel Disease Patients at Risk for HZ|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||July 31, 2019|
Non-immunosuppressed IBD patients
24 IBD patients on mesalamine therapy or no IBD therapy
12 IBD patients on azathioprine at least 2.0mg/kg or 6MP 1.0mg/kg
12 IBD patients on maintenance therapy infliximab (at least 8 every 8 weeks), golilumab (at least monthly), adalilumab (at least every 2 weeks), or certolizumab (at least monthly)
12 IBD patients on anti-TNF therapy as described in group along with either 15mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
The control group with consist of 12 individuals who meet the following inclusion and exclusion criteria.
Individuals will be obtained from patients without an IBD diagnosis, chronic liver disease, celiac disease or other chronic health condition coming to Digestive Health Center for endoscopic procedures or clinic visits.
12 IBD patients on vedolizumab maintenance therapy every 4-8 weeks
Prednisone and Anti-TNF therapy
12 IBD patients on Anti-TNF maintenance therapy as combination or mono therapy along with at least 10mg of prednisone
- Immune response by T cell, cell mediated immunity, to varicella zoster virus in patients with inflammatory bowel disease. [ Time Frame: Day 1 ]ELISPOT is an enzyme-linked assay for detecting and enumerating cytokine-producing lymphocytes. ELISPOT can detect cytokine-producing cells in as few as 1 in 300,000 cells. ELISPOT is the standard for measuring varicella cell mediated immunity.
- Immune response by T cells ,cell Mediated Immunity, to varicella zoster virus in Immunosuppressed patients with IBD compared to those non-Immunosuppressed [ Time Frame: Day 1 ]ELISPOT is an enzyme-linked assay for detecting and enumerating cytokine-producing lymphocytes. ELISPOT can detect cytokine-producing cells in as few as 1 in 300,000 cells. ELISPOT is the standard for measuring varicella cell mediated immunity.
- Immune response by T cell, cell mediated immunity, to varicella zoster virus in Immunosuppressed IBD patients compared to other immunosuppressed IBD patients [ Time Frame: Day 1 ]ELISPOT is an enzyme-linked assay for detecting and enumerating cytokine-producing lymphocytes. ELISPOT can detect cytokine-producing cells in as few as 1 in 300,000 cells. ELISPOT is the standard for measuring varicella .
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553472
|Contact: Lindsey Luedkeemail@example.com|
|Contact: Freddy Caldera, DOfirstname.lastname@example.org|
|United States, Wisconsin|
|University of Wisconsin Digestive Health Center||Recruiting|
|Madison, Wisconsin, United States, 53705|
|Contact: Lindsey Leudke email@example.com|
|Contact: Freddy Caldera firstname.lastname@example.org|
|Principal Investigator: Freddy Caldera, DO|
|Principal Investigator:||Freddy Caldera, DO||University of Wisconsin School of Medicine|