Measuring Effects of High-fiber Dried Chicory Root on the Gut Microbiota of Patients With an Intermediate to High-risk Cutaneous Melanoma: an Explorative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effect of a high fiber prebiotic vegetable (WholeFiber) on fecal SCFA levels
研究概览
简要总结
Exploring the effect of supplementation with daily addition of prebiotic dried chicory root (WholeFiberTM) for 6 weeks on fecal SCFA levels, gut microbial composition and immune cell composition in minimal stage II A melanoma patients following surgical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •The participant understands the study and can provide written informed consent;
- •The participant received surgical treatment of an intermediate to high-risk cutaneous melanoma (T2a/N1, T2b, T3a, T3b, T4a, T4b, N0 or N+, M0 stadium without evidence of disease);
- •Being able to read and speak Dutch;
- •Willing to come to the UMCG for practical reasons (visiting the study site);
- •Willing to continue their regular lifestyle patterns during the study.
排除标准
- •Receiving concurrent adjuvant treatment, adjuvant treatment after the study period is allowed.
- •Having a medical history that may impact study outcomes, such as a diagnosis of diabetes mellitus type 2, heart disease, renal disease, autoimmune disease;
- •Any clinically significant or unstable medical disorder involving the gut, including celiac disease, inflammatory bowel disease, short-bowel syndrome or acute/chronic pancreatitis;
- •Having an ileostomy or colostomy, as this greatly impacts bowel function and gut microbial composition;
- •Use of antibiotics in the 3 months prior participation in the study;
- •Use of prednisolone or other immunosuppressive medication;
- •Use of tube feeding or sib-feeding;
- •Being pregnant or lactating;
- •Participation in another interventional study at the same time;
- •Unable or unwilling to comply to study rules.
研究组 & 干预措施
prebiotic dried chicory root (WholeFiber)
Supplementing with WholeFiber for 6 weeks two times a day (10 g per portion). During 3 visits questionnaires, measurements and (blood and fecal) samples will be taken.
干预措施: prebiotic dried chicory root (WholeFiber) (Other)
结局指标
主要结局
Effect of a high fiber prebiotic vegetable (WholeFiber) on fecal SCFA levels
时间窗: 6 weeks
Effect of a high fiber prebiotic vegetable (WholeFiber) for 6 weeks on fecal SCFA levels in intermediate to high-risk cutaneous melanoma patients, with no concurrent adjuvant treatment. HPLC ion chromatography system (Metrohm AG, Herisau, Switzerland) will be used to determine the levels of SCFA. The concentrations of SCFA; butyrate, propionate, and acetate will be measured with a conductivity detector. SCFA will be measured at baseline, halfway intervention and after 6 weeks.
Effect of a high fiber prebiotic vegetable (WholeFiber) on fecal SCFA levels
时间窗: 6 weeks
Effect of a high fiber prebiotic vegetable (WholeFiber) for 6 weeks on fecal SCFA levels in intermediate to high-risk cutaneous melanoma patients, with no concurrent adjuvant treatment. HPLC ion chromatography system (Metrohm AG, Herisau, Switzerland) will be used to determine the levels of SCFA. The concentrations of SCFA; butyrate, propionate, and acetate will be measured with a conductivity detector. SCFA will be measured at baseline, halfway intervention and after 6 weeks.
次要结局
- Discovering the gut microbial composition changes(6 weeks)
- Exploring the effect of WholeFiber use(6 weeks)
- Discovering the gut microbial composition changes(6 weeks)
- Exploring the effect of WholeFiber use(6 weeks)