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NCT05584735 | RECRUITING | Inflammatory Bowel Diseases

Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine
Sponsor:

University of Wisconsin, Madison

Brief Summary:

This study will evaluate the effect of the microorganisms in the gut on how well the flu or COVID-19 vaccine works in people who have a weakened immune system due to inflammatory bowel disease. Participants can expect to be in the study for up to 65 days.

Condition or disease

Inflammatory Bowel Diseases

Intervention/treatment

Influenza vaccine

COVID-19 vaccine

Detailed Description:

The overall objective of this study is to evaluate the role of gut microbiome in influenza or COVID-19 vaccine response in immunosuppressed populations. Microbial diversity (alpha diversity) is decreased in immunosuppressed patients and might be associated with lower immunogenicity to vaccines. It is known that patients with IBD have dysbiosis of their gut microbiome and those immunosuppressed may have a lower vaccine response. In this aim, the investigators will evaluate whether differences in microbial diversity predict immune response to the influenza and COVID-19 vaccine. In this prospective study, immunosuppressed IBD patients will be vaccinated per standard of care and blood will be collected to measure the immune response. A fecal and saliva sample will be collected to characterize the gut microbiome. The investigators hypothesize that reduced richness / alpha-diversity in gut microbiota will correlate with those with a blunted vaccine response.

Study Type : OBSERVATIONAL
Estimated Enrollment : 60 participants
Official Title : Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine in Immunosuppressed Patients With Inflammatory Bowel Disease
Actual Study Start Date : 2023-11-03
Estimated Primary Completion Date : 2025-09
Estimated Study Completion Date : 2025-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 64 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic, and histopathologic criteria
  • * Currently one of the following groups
    • 1. Group A: Anti-TNF Therapy Group
    • * Maintenance monotherapy: infliximab (at least every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)
    • * Combination Therapy: Anti-TNF Combination Therapy Group on anti-TNF therapy as described above along with either methotrexate, azathioprine, or 6MP
    • 2. Group B: Non-TNG biologic
    • * Ustekinumab Therapy: on either ustekinumab monotherapy or combination therapy with methotrexate, azathioprine, or 6MP
    • * Vedolizumab Therapy: on either vedolizumab monotherapy or combination therapy with methotrexate, azathioprine, or 6MP
    • * Risankizumab Therapy: 360mg at least every 8 weeks
    • 3. Group C: Janus Kinase Therapy
    • * Tofacitinib Therapy: at least 5mg PO BID
    • * Upadactinib Therapy: at least 15mg PO daily
    • * Patient has been on stable treatment for IBD for at least three months
    • * Must be able to provide research samples between 28-65 days post influenza or Covid-19 vaccination.
    Exclusion Criteria
    • * Member of a vulnerable group (pregnant, lacking consent capacity, non-English speaking)
    • * Recent oral antibiotics within previous 2 months
Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine

Location Details

NCT05584735

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Locations

RECRUITING

United States, Wisconsin

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States, 53792