Dried chicory root fiber alongside immunotherapy for advanced melanoma
Tests dried chicory root fiber versus placebo in adults with metastatic melanoma.
Plain-language title generated from the registry record
Registry title: Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.
Key facts
- Where
- Groningen and Nijmegen, NetherlandsSee the 2 sites
- Phase
- Phase 2
Where in Netherlands
- Universitair Medisch Centrum GroningenGroningen, NetherlandsNot yet recruiting
- Medical OncologyNijmegen, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Radboud University Medical Center
- Trial code
- NCT07686835
- Record updated
- 27 July 2026
- Original description
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.Read full original descriptionShow less
Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.
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.
Inclusion: Histologically confirmed cutaneous melanoma classified as irresectable stage III or stage IV disease; Measurable disease according to RECIST 1.1 criteria; Age ≥ 18 years; Starting standard-of-care treatment with ICI in first line; Written informed consent must be given; Able to read and understand Dutch or English; Able to comply with study procedures (e.g. willing to provide fecal samples).
Exclusion: Received prior immunotherapy; previous (neo)adjuvant treatment is allowed if the last administration is at least 6 months ago; Use of systemic immunosuppressive medications; Use of laxatives up to 1 week prior to start of ICI; Use of supplements that alter bowel function or gut microbiota such as fibers/prebiotics, probiotics, synbiotics, or postbiotics up to 1 month prior to start of ICI; Use of antibiotics up to 1 months prior to start of ICI; Use of proton pumps inhibitors (PPI's) up to 3 months prior to start of ICI; Current participation in another clinical trial requiring the use of study medication; Has a known allergy to plants such as lettuce, sage, tarragon, chicory, artichoke, chamomile, daisy, or sunflower; Has a medical history of gastrointestinal resection (appendectomy is allowed); Has active inflammatory bowel disease; Symptomatic brain metastases; Pregnant or lactating.