NCT05584735Completed
Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine
Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine in Immunosuppressed Patients With Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 31 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 46 (actual)
- First submitted
- 14 Oct 2022
- Start date
- 3 Nov 2023
- Primary completion date
- 20 Mar 2025
- Lead sponsor
- University of Wisconsin, Madison
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05584735
What you commit to
- Study type: Observational
- Participants enrolled: 46
- From 3 Nov 2023 to the primary completion date, 20 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent oral antibiotics within previous 2 months
Other
- Member of a vulnerable group (pregnant, lacking consent capacity, non-English speaking)
Who the study is looking for
- 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:
- 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
- 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
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.