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

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Conditions

Inflammatory Bowel DiseasesCrohn's diseaseulcerative colitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-03
Study Completion:2025-03-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05584735

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.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Currently one of the following groups:
  3. 1. Group A: Anti-TNF Therapy Group
  4. * Maintenance monotherapy: infliximab (at least every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)
  5. * Combination Therapy: Anti-TNF Combination Therapy Group on anti-TNF therapy as described above along with either methotrexate, azathioprine, or 6MP
  6. 2. Group B: Non-TNG biologic
  7. * Ustekinumab Therapy: on either ustekinumab monotherapy or combination therapy with methotrexate, azathioprine, or 6MP
  8. * Vedolizumab Therapy: on either vedolizumab monotherapy or combination therapy with methotrexate, azathioprine, or 6MP
  9. * Risankizumab Therapy: 360mg at least every 8 weeks
  10. 3. Group C: Janus Kinase Therapy
  11. * Tofacitinib Therapy: at least 5mg PO BID
  12. * Upadactinib Therapy: at least 15mg PO daily
  13. * Patient has been on stable treatment for IBD for at least three months
  14. * Must be able to provide research samples between 28-65 days post influenza or Covid-19 vaccination.
  1. * Member of a vulnerable group (pregnant, lacking consent capacity, non-English speaking)
  2. * Recent oral antibiotics within previous 2 months

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-03
Study Completion Date2025-03-20

Study Record Updates

Study Start Date2023-11-03
Study Completion Date2025-03-20

Terms related to this study

Keywords Provided by Researchers

  • Crohn's disease
  • ulcerative colitis

Additional Relevant MeSH Terms

  • Inflammatory Bowel Diseases