About this trial
To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old
English-speaking
Body mass index (BMI) 18.5-45 kg/m2
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Disqualifiers
Previous ICB treatment in the metastatic setting
History of inflammatory bowel disease, total colectomy, or bariatric surgery.
Currently taking steroids > Prednisone 10 mg/day or equivalent
Medical contraindications to the Intervention Diet as determined by the treating physician.
Trial design
Single group
Treatments tested in this trial
Prebiotic Food-Enriched Diet
Other interventionGiven by PO
Treatment groups
Trial outcomes
Primary outcomes
Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline.
Sponsors and contacts
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