Explorative Study on Addition of High-fiber Dried Chicory Root in Patients With an Intermediate to High-risk Cutaneous Melanoma.
Recruiting · NCT07206017 · Interventional (participants receive a specific treatment) · Lead sponsor: University Medical Center Groningen
View the official record on ClinicalTrials.gov →Interventions studied
prebiotic dried chicory root (WholeFiber)
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →