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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06466434
Phase
PHASE2
Status
Recruiting
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Conditions

  • Unresectable Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prebiotic Food-Enriched Diet — OTHER
    Given by PO

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2029

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Prebiotic food-enriched diet (PreFED)
    Participants will receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in the diet.

Primary Outcome Measure

Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline. [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Erez Baruch, MD,PHD
[email protected],
713-745-5530
Erez Baruch, MD,PHD (PRINCIPAL_INVESTIGATOR)

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By research site
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