Dietary Fiber Supplementation to Enhance Gut Bacteria and Immunotherapy Response in Advanced Melanoma

What this Trial Is About

Researchers are studying whether increasing dietary fiber intake can improve the immune response to immunotherapy in patients with advanced melanoma. This phase 2 clinical trial aims to see if a higher fiber intake increases the amount of beneficial gut bacteria called Bifidobacterium, which may stimulate immune cells and enhance the effectiveness of immunotherapy treatments for metastatic melanoma. Participants are randomly assigned to receive either dried chicory roots providing 18.5 grams of additional fiber daily or an isocaloric placebo made of rice puffs. The intervention lasts for 3 to 4 weeks starting alongside standard immunotherapy treatment. This study is double-blinded and evaluates the effects of fiber supplementation compared to placebo on gut bacteria and immune response. Participants provide fecal samples at baseline, 3-4 weeks, 3-4 months, and 6-7 months to monitor changes in gut microbiota. Researchers also assess radiological response to immunotherapy, progression-free survival, overall survival, and gastrointestinal side effects over a follow-up period of up to 5 years. Study-related procedures include monitoring immune response and safety throughout the study period.

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