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RECRUITING
NCT07686835
PHASE2

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

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-07-31

Completion Date

2029-04-30

Last Updated

2026-07-27

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Dried 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_SUPPLEMENT

Placebo

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