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ACTIVE NOT RECRUITING
NCT06504784
NA

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

Sponsor: Sahlgrenska University Hospital

View on ClinicalTrials.gov

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.

Official title: Effect of Dietary Fiber on Gut Microbiota Composition and Immune Response to Influenza Vaccination in Ulcerative Colitis Patients on Immunosuppressive Therapy: A Randomized, Double-blind, Placebo-controlled Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-09-14

Completion Date

2025-10

Last Updated

2024-07-19

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Dietary Fiber Mixture

10g/day of dietary fibre mixture - a mixture of oligo-and polysaccharides

OTHER

Placebo

10g/day of placebo (glucose)

Locations (1)

Sahlgrenska University Hospital

Gothenburg, Sweden