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

NCT06504784 | Active Not Recruiting

• 1 other identifier: PreVac2023
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 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

Ulcerative Colitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Effect of dietary fiber intake on metabolite composition in UC patients and healthy controls comparing baseline vs. end of 6 week oral intervention.

  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).]

Study Arms (2)

Dietary Fibre Mixture

EXPERIMENTAL

Study participants receive 10g/day of dietary fibre mixture (a mixture of oligo-and polysaccharides), divided into two doses and administered orally for 6 weeks.

Dietary Supplement: Dietary Fiber Mixture

Placebo

PLACEBO COMPARATOR

Study participants receive 10g/day of placebo (glucose) matching the fibre mixture in colour and flavor, divided into two doses and administered orally for 6 weeks.

Other: Placebo

Interventions

Dietary Fiber Mixture DIETARY_SUPPLEMENT

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

Dietary Fibre Mixture

Placebo OTHER

10g/day of placebo (glucose)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Inflammatory bowel disease or suspicion thereof

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Calmino group AB: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization and Concealed allocation will be assured by the distribution of investigational products by a nurse/researcher at the unit, otherwise not involved in the conduct of the study. The randomization schedule will be kept in a locked cabinet until the completion of the trial and all data had been entered into a computer database. Both the investigators and the participants will be blinded to treatment arm assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, associate professor

Model Details: Randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: July 17, 2024
• Study Start: September 14, 2023
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)