Clinical trial · Interventional
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
NCT07206017CI-TRIAL-00096271MELFIBrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma, Stage II | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prebiotic dried chicory root (WholeFiber) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- prebiotic dried chicory root (WholeFiber)
- description
- 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.
- interventionNames
- Other: prebiotic dried chicory root (WholeFiber)
Primary outcomes (1)
- measure
- Effect of a high fiber prebiotic vegetable (WholeFiber) on fecal SCFA levels
- timeFrame
- 6 weeks
- description
- 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 (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.