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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07206017
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Medical Center Groningen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	G. A.P. Hospers, MD, PhD
Principal Investigator Affiliation	UMCG
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma, Stage II

Arms & Interventions

Arms

Experimental: 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.

Interventions

Other: - prebiotic dried chicory root (WholeFiber)

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

UMCG, Groningen 2755251, Provincie Groningen 2755249, Netherlands

Status

Recruiting

Address

UMCG

Groningen 2755251, Provincie Groningen 2755249, 9713 GZ

Site Contact

G. A.P. Hospers, MD, PhD

[email protected]

+31 50 361 2821

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