Status:
ACTIVE_NOT_RECRUITING
The Role of Gut Bacteria in the Immune Response to Vaccination in Patients With Ulcerative Colitis
Lead Sponsor:
Sahlgrenska University Hospital
Collaborating Sponsors:
Calmino group AB
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 altere...
Detailed Description
Project Description: 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. The...
Eligibility Criteria
Inclusion
- UC patients, aged 18-65, in remission, with stable maintenance treatment for at least 6 months consisting of anti-TNF medications and/or thiopurines, or 5-ASA.
- Healthy volunteers, aged 18-65.
Exclusion
- Comorbidity according to the Charlston Comorbidity Index
- Ongoing immunosuppressive treatment for a condition other than inflammatory bowel disease
- Colorectal surgical treatment for inflammatory bowel disease
- Treatment with antibiotics in the past 3 months
- Intake of probiotic or prebiotic dietary supplements in the past 3 months
- Inability to understand information about the study or provide informed consent
- Additional Exclusion Criteria for Healthy Volunteers:
- Inflammatory bowel disease or suspicion thereof
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06504784
Start Date
September 14 2023
End Date
October 1 2025
Last Update
July 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345