RecruitingPhase 2NCT07686835

Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.


Sponsor

Radboud University Medical Center

Enrollment

70 participants

Start Date

Jul 31, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Previous research has shown that a higher fiber intake may have a beneficial effect on the intestinal health and improve the effectiveness of immunotherapy, but this is not certain. The objective of this double-blinded randomized clinical trial is to analyze, whether increased dietary fiber intake by patients with metastatic melanoma will increase the relative amount of Bifidobacterium, which in turn stimulates immune cell activity and improves the response to immunotherapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Dried chicory roots and Placebo for people with melanoma, melanoma (skin cancer), and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTDried chicory roots

The dried chicory roots are implemented using a dosage of 22.5 gram/day resulting in 18.5 gram additional fibers a day.

DIETARY_SUPPLEMENTPlacebo

The control arm will receive 12.4 grams of placebo a day, isocaloric to the intervention.


Locations(2)

Medical Oncology

Nijmegen, Gelderland, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Provincie Groningen, Netherlands

View Full Details on ClinicalTrials.gov

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NCT07686835


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