Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

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

Qualifiers

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

Treatments tested in this trial

  • Prebiotic Food-Enriched Diet

Treatment groups

75 Participants
are divided into 1 treatment group

Sponsors and collaborators