Clinical Trial

The Role of Gut Bacteria in the Immune Response to Vaccination in Patients With Ulcerative Colitis

Unknown
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Summary
Patients with the inflammatory bowel disease ulcerative colitis (UC) are a high-risk group encouraged to get vaccinated against seasonal influenza. It is also known that UC patients may have an altered gut microbiota. Patients with more severe disease are treated with immunosuppressive medications such as thiopurines and biologics that block pro-inflammatory cytokines. However, these treatments makes patients more susceptible to infections and results in a poorer response to certain types of vaccinations, as the immunosuppressive treatment aims to suppress mechanisms in the immune response. The purpose of the study is to determine if dietary fibers can improve the immune response to influenza vaccination in UC patients treated with immunosuppressive medications. Further, the study aims to determine if dietary fibers (prebiotics) can enrich the composition and function of the gut microbiota in UC patients.
Protocol Amendment History 1 change
critical Trial status changed: Active, Not Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06504784
Lead Sponsor Sahlgrenska University Hospital
Collaborators: Calmino group AB
Conditions Ulcerative Colitis
Enrollment 150 participants
Start Date 2023-09-14
Primary Completion 2024-07 (estimated)
Study Completion 2025-10 (estimated)
Updated on ClinicalTrials.gov 2024-07-19