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Recruiting NCT07206017

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

No phase Interventional Melanoma, Stage II

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: prebiotic dried chicory root (WholeFiber).
Who it may be relevant to
Registry conditions: Melanoma, Stage II. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other prebiotic dried chicory root (WholeFiber)
    Supplementing with WholeFiber for 6 weeks two times a day (10 g per portion).

Primary outcome measures

  • Effect of a high fiber prebiotic vegetable (WholeFiber) on fecal SCFA levels [Time frame: 6 weeks]
Secondary outcome measures (2)
  • Discovering the gut microbial composition changes [Time frame: 6 weeks]
  • Exploring the effect of WholeFiber use [Time frame: 6 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Netherlands · 1 center
  • UMCG — Groningen

Identifiers

NCT: NCT07206017 · 19789

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗