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Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.

NCT07686835 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-07-27

No results posted yet for this study

Summary

Previous research has shown that a higher fiber intake may have a beneficial effect on the intestinal health and improve the effectiveness of immunotherapy, but this is not certain. The objective of this double-blinded randomized clinical trial is to analyze, whether increased dietary fiber intake by patients with metastatic melanoma will increase the relative amount of Bifidobacterium, which in turn stimulates immune cell activity and improves the response to immunotherapy.

Conditions

  • Melanoma (Skin) Stage IV
  • Melanoma (Skin Cancer)
  • Melanoma Metastatic
  • Melanoma Advanced
  • Melanoma

Interventions

DIETARY_SUPPLEMENT

Dried chicory roots

The dried chicory roots are implemented using a dosage of 22.5 gram/day resulting in 18.5 gram additional fibers a day.

DIETARY_SUPPLEMENT

Placebo

The control arm will receive 12.4 grams of placebo a day, isocaloric to the intervention.

Sponsors & Collaborators

  • Wageningen University and Research

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-05-01
Completion
2029-04-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07686835 on ClinicalTrials.gov