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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Effect of a high fiber prebiotic vegetable (WholeFiber) on fecal SCFA levels
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: prebiotic dried chicory root (WholeFiber) (Other)
Outcomes
Primary Outcomes
Effect of a high fiber prebiotic vegetable (WholeFiber) on fecal SCFA levels
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)