Clinical trial · Interventional
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
NCT06466434CI-TRIAL-00117506recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unresectable Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prebiotic Food-Enriched Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prebiotic food-enriched diet (PreFED)
- description
- Participants will receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in the diet.
- interventionNames
- Other: Prebiotic Food-Enriched Diet
Primary outcomes (1)
- measure
- Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline.
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.