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Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.
Sponsor: Radboud University Medical Center
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
Conditions
Interventions
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.
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