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RECRUITINGINTERVENTIONAL

Explorative Study on Addition of High-fiber Dried Chicory Root in Patients With an Intermediate to High-risk Cutaneous Melanoma.

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18 years; - The participant understands the study and can provide written willing to sign a consent form; - 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. Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body); - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

OTHER

prebiotic dried chicory root (WholeFiber)

Supplementing with WholeFiber for 6 weeks two times a day (10 g per portion).

Locations (1)

UMCG
Groningen, Provincie Groningen, Netherlands