Examining how gut bacteria affect vaccine response in IBD patients
Determining the Relationship Between Gut Microbiota and Immune Response to Influenza or COVID-19 Vaccine in Immunosuppressed Patients With Inflammatory Bowel Disease
This study is trying to see how gut bacteria affect how well people with inflammatory bowel diseases respond to flu and COVID-19 vaccines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Drugs / interventions | infliximab, golimumab, adalimumab, certolizumab, Ustekinumab, Vedolizumab, Risankizumab, Tofacitinib, Upadactinib, methotrexate |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05584735 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the impact of gut microbiota on the immune response to influenza and COVID-19 vaccines in patients with inflammatory bowel diseases (IBD) who are immunosuppressed. Participants will be vaccinated according to standard care, and their blood, fecal, and saliva samples will be collected to assess immune response and characterize gut microbiome diversity. The study hypothesizes that lower microbial diversity may correlate with a reduced vaccine response, providing insights into how gut health influences vaccine efficacy in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates include individuals with a documented history of Crohn's disease or ulcerative colitis who are currently receiving immunosuppressive therapy.
Not a fit: Patients without inflammatory bowel diseases or those not on immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved vaccination strategies for patients with inflammatory bowel diseases, enhancing their immune response.
How similar studies have performed: While the relationship between gut microbiota and vaccine response is an emerging field, similar studies have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madison, Wisconsin
- University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Freddy Caldera, DO, MS — University of Wisconsin, Madison
- Study coordinator: Freddy Caldera, DO, MS
- Email: fcaldera@medicine.wisc.edu
- Phone: 608-263-1995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.