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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prebiotic dried chicory root (WholeFiber) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prebiotic dried chicory root (WholeFiber) | Other | Supplementing with WholeFiber for 6 weeks two times a day (10 g per portion). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of a high fiber prebiotic vegetable (WholeFiber) on fecal SCFA levels | 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Discovering the gut microbial composition changes | Discovering the gut microbial composition changes measured in intermediate to high-risk cutaneous melanoma patients with no concurrent adjuvant treatment, after using WholeFiber for 6 weeks. This analysis will be based on whole genome sequencing of fecal samples performed at the UMCG according to standardized protocol. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| G. A.P. Hospers, MD, PhD | Contact | +31 50 361 2821 | g.a.p.hospers@umcg.nl | |
| Emily Oosterhout, MSc | Contact | +31652764949 | e.oosterhout@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| G. A.P. Hospers, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMCG | Recruiting | Groningen | Provincie Groningen | 9713 GZ | Netherlands |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 26, 2025 | Jul 9, 2025 |
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| Exploring the effect of WholeFiber use | Exploring the effect of WholeFiber use for 6 weeks on immune functioning, stool patterns, fecal calprotectin levels and side effects in this patient group. Peripheral blood mononuclear cells (PBMCs) and bloodplasma will be isolated to determine immune cell composition before and after the intervention period. Fecal calprotectin will be determined using the respective ELISA kit (Thermo Fisher Scientific). Calprotectin is released when neutrophils enter the gut wall and are activated during the inflammatory process. Lastly, eating patterns, fiber intake before the interventional period, stool patterns and side effects will be identified using the Food Frequency Questionnaire, Bristol Stool Scale, Gastrointestinal Symptoms Rating Scale and Health Related Quality of Life questionnaires. | 6 weeks |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 26, 2025 | Sep 24, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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