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

Description

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.

Conditions

Inflammatory Bowel Diseases

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Study Overview

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Study Details

Study overview

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.

Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine in Immunosuppressed Patients With Inflammatory Bowel Disease

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

Condition
Inflammatory Bowel Diseases
Intervention / Treatment

-

Contacts and Locations

Madison

University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Member of a vulnerable group (pregnant, lacking consent capacity, non-English speaking)
  • * Recent oral antibiotics within previous 2 months

Ages Eligible for Study

18 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Wisconsin, Madison,

Freddy Caldera, DO, MS, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

2025-09