The Role of Gut Bacteria in the Immune Response to Vaccination in Patients With Ulcerative Colitis
NCT Number: NCT06504784
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ulcerative Colitis
Interventions: DIETARY_SUPPLEMENT: Dietary Fiber Mixture|OTHER: Placebo
Sponsor: Sahlgrenska University Hospital, Sweden
Collaborators: Calmino group AB
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-14
Completion Date: 2025-10
Locations: Sahlgrenska University Hospital, Gothenburg, 41345, Sweden

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.

Primary Outcome Measures: The level of influenza-specific antibodies (titers) in blood samples measured post-vaccination., The level of influenza-specific antibodies (titers) in blood samples of UC patients measured post-vaccination in intervention group (receiving dietary fiber) compared to patients in the placebo group., Measured at Visit 2 (day of vaccination), Visit 3 (3-4 weeks post-vaccination), and Visit 4 (20-25 weeks post-vaccination).|Effect of Dietary Fibers on Gastrointestinal Symptoms using the validated Gastrointestinal Symptom Rating Scale (GSRS) questionnaire in Patients with Ulcerative Colitis comparing baseline vs. end of 6 week oral intervention with dietary fiber., GI symptoms are assessed using the validated Gastrointestinal Symptom Rating Scale (GSRS). GSRS is a 15 item measure of IBS symptom severity. The scale measures the severity of each symptom on a scale from 1 to 7. Maximum total score is 7 and minimum score is 1, where a higher score indicates higher gastrointestinal symptom severity., GI symptoms using GSRS symptom questionnaire were assessed at baseline and at 3 week and 6 weeks after intervention|Effect of Dietary Fibers on disease activity assessed using a modified Mayo score form in Patients with Ulcerative Colitis comparing baseline vs. end of 6 week oral intervention., Disease activity is assessed using a modified Mayo score (UC patients only). Mayo score measures disease activity on a scale from to 6, where the maximum score is 6 and minimum score is 0, and higher score indicated worse outcome with regards to disease activity. Change in total Mayo score will be evaluated., Mayo score (modified) will be measured at baseline and at 3 week and 6 weeks after intervention
Secondary Outcome Measures: Effect of dietary fiber intake on metabolite composition in UC patients and healthy controls comparing baseline vs. end of 6 week oral intervention., Change in metabolite profile/composition in UC patients and healthy controls after intervention with dietary fiber compared to placebo will be established. Fecal samples will be used to evaluate the Metabolite profile using untargeted Liquid chromatography coupled to a mass spectrometer (LC-MS). Change in the metabolite profile measured as metabolite signal response from Baseline to 6 Weeks after intervention will be evaluated., Analyzed from fecal samples collected at Visit 1 (baseline), Visit 2 (day of vaccination), Visit 3 (3-4 weeks post-vaccination), and Visit 4 (20-25 weeks post-vaccination).]