Melanoma, Stage IIMELFIBNCT07206017
Explorative Study on Addition of High-fiber Dried Chicory Root in Patients With an Intermediate to High-risk Cutaneous Melanoma.
A study testing prebiotic dried chicory root (WholeFiber) in people with Melanoma, Stage II, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Stage II
- What is being tested?
- prebiotic dried chicory root (WholeFiber)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Mar 2025to 14 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
UMCG
Groningen, Provincie Groningen, 9713 GZ
G. A.P. Hospers, MD, PhD, +31 50 361 2821, g.a.p.hospers@umcg.nl
Emily Oosterhout, MSc, +31652764949, e.oosterhout@umcg.nl
About this study
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
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
- Melanoma, Stage II
- Being tested
- prebiotic dried chicory root (WholeFiber)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prebiotic dried chicory root (WholeFiber)Other
Supplementing with WholeFiber for 6 weeks two times a day (10 g per portion).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: prebiotic dried chicory root (WholeFiber) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (2)
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start26 Mar 2025
- Primary completion25 Mar 2026 (estimated)
- Study completion14 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma, Stage IIStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- G. A.P. Hospers, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206017
- Sponsor's protocol ID
- 19789
- Acronym
- MELFIB
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07206017
- Acronym / sponsor ID
- MELFIB / 19789
- Conditions
- Melanoma, Stage II
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 25 Mar 2026 (estimated)
- Study completion
- 14 Sep 2027 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prebiotic dried chicory root (WholeFiber) | Experimental | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prebiotic dried chicory root (WholeFiber)Supplementing with WholeFiber for 6 weeks two times a day (10 g per portion). | Other | prebiotic dried chicory root (WholeFiber) |
Primary outcome
Effect of a high fiber prebiotic vegetable (WholeFiber) on fecal SCFA levels
Time frame: 6 weeks
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.
2 secondary outcomes
Discovering the gut microbial composition changes
Time frame: 6 weeks
Exploring the effect of WholeFiber use
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
G. A.P. Hospers, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prebiotic dried chicory root (WholeFiber) in people with Melanoma, Stage II, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact G. A.P. Hospers, MD, PhD (+31 50 361 2821, g.a.p.hospers@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of a high fiber prebiotic vegetable (WholeFiber) on fecal SCFA levels (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.