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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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 investigators also intend to determine if dietary fibers (prebiotics) can enrich the composition and function of the gut microbiota in UC patients.
Background and Justification:
Patients with moderate to severe UC often require lifelong medical treatment. Long-term treatment typically includes medications such as 5-ASA, immunomodulatory agents like thiopurines, and/or antibodies or biologics that block pro-inflammatory cytokines. These medical treatments aim to suppress the patient's inflammatory activity both systemically and locally in the gut. The treatment is often effective, leading to complete or partial healing of gut inflammation, known as remission. Unfortunately, the treatment also makes patients more susceptible to infections and results in a poorer response to certain types of vaccinations.
Patients with UC are a high-risk group and are encouraged to vaccinate against the seasonal influenza virus. Vaccination activates immune cells to produce antibodies that protect against the influenza virus. The effectiveness of the vaccination is measured by the levels (titers) of influenza-specific antibodies formed. Previous studies have shown that patients treated with biologics such as antibodies against the pro-inflammatory cytokine TNF, have a poorer response to various vaccinations, including influenza, and therefore receive less protection against the infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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.
时间窗: Mayo score (modified) will be measured at baseline and at 3 week and 6 weeks after 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.
The level of influenza-specific antibodies (titers) in blood samples measured post-vaccination.
时间窗: Measured at Visit 2 (day of vaccination), Visit 3 (3-4 weeks post-vaccination), and Visit 4 (20-25 weeks 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.
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.
时间窗: GI symptoms using GSRS symptom questionnaire were assessed at baseline and at 3 week and 6 weeks after intervention
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.
次要结局
- 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).])
研究者
Jóhann P. Hreinsson
MD, PhD, associate professor
Sahlgrenska University Hospital