Recruiting
Phase 2

Prebiotic Diet

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06466434

Conditions

Unresectable Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prebiotic Food-Enriched Diet

Study Details

Brief summary:

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.

Conditions

Unresectable Melanoma

Study ID

NCT06466434

Start date

Sep 1, 2024

Status verified date

Mar, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Histologically confirmed stage III/IV, unresectable cutaneous, uveal, acral or mucosal melanoma. Asymptomatic brain metastases are allowed.
  • Planned initiation of 1st line standard-of-care approved immune checkpoint blockade (anti-PD1 +/- anti-CTLA4 or anti-LAG3 inhibitors or talimogene laherparepvec T-VEC) in the metastatic setting. Prior targeted therapy or ICB in the adjuvant setting is allowed.
  • Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally)
  • Measurable disease per RECIST 1.1 or RANO criteria. Up to 10 patients without measurable can be enrolled.
  • WOCP must have negative UPT within 1 week of beginning dietary intervention.
  • Self-reported willingness to eat the provided foods (with some tailoring to their food preferences)
  • Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.

Exclusion Criteria:

  • 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.
  • Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting.
  • Insulin-dependent diabetes or condition requiring bile acid sequestrants
  • Unable or unwilling to undergo study procedures.
  • IV antibiotic use in the past month or oral antibiotic use in past 2 weeks.
  • Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study.
  • Current smoker or heavy drinker (defined as >14 drinks per week) or current illicit drug use.
  • Currently pregnant, planning to become pregnant, or lactating.
  • Concurrent malignancy requiring systemic therapy other than hormonal therapy.
  • Cognitively impaired adults

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Prebiotic Food-Enriched Diet

Given by PO

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 and Locations

Central contacts

Erez Baruch, MD,PHD

713-745-5530ENBaruch@mdanderson.org,

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Erez Baruch, MD,PHD

713-745-5530ENBaruch@mdanderson.org,

Principal Investigator:

Erez Baruch, MD,PHD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 10, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-10.