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

NCT06504784 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-07-19

No results posted yet for this study

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.

Conditions

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)

Sponsors & Collaborators

  • Calmino group AB

    collaborator UNKNOWN

  • Sahlgrenska University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-14
Primary Completion
2024-07-31
Completion
2025-10-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06504784 on ClinicalTrials.gov