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Could prebiotic snacks boost melanoma treatment?

NCT ID NCT06548789

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding a prebiotic-rich diet to standard immunotherapy before surgery can improve immune response in people with melanoma. About 35 adults with resectable melanoma will receive prebiotic snack packs and diet counseling alongside their usual treatment. The main goal is to see if patients can stick with the diet and how it affects their gut microbiome and treatment outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prebiotic snack packouts and dietary counseling
What this could lead to
If it works, this could show that adding prebiotic foods to standard immunotherapy improves treatment response in melanoma patients.
What could go wrong
This is a small, early-phase trial with only 35 participants, so results may not apply to everyone. The diet may be hard to follow, and it's unclear if it will meaningfully improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years old. 2. Body mass index (BMI) 18.5-45 kg/m2 3. Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden 4. ECOG performance status of 0 or 1 5. Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by multidisciplinary review 6. Planned initiation of standard-of-care neoadjuvant ipilimumab +/- nivolumab or nivolumab +/- relatlimab 7. Measurable disease per RECIST 1.1 8. WOCP must have negative UPT within 1 week of beginning dietary intervention. 9. Self-reported willingness to eat the provided foods (with some tailoring to their food preferences) 10. Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples. 11. Archival tissue specimen or planned to undergo tumor biopsy as part of standard of care treatment. Exclusion Criteria: 1. Uveal melanoma 2. History of inflammatory bowel disease, total colectomy, or bariatric surgery 3. Currently taking steroids \> prednisone 10 mg/day or equivalent 4. Medical contraindications to the intervention diet as determined by the treating physician 5. Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting 6. Insulin-dependent diabetes or conditions requiring bile-acid sequestrants 7. Unable or unwilling to undergo study procedures 8. Intravenous (IV) antibiotic \>1 dose in the past month or 1 dose IV/oral antibiotic use in past 2 weeks 9. Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study 10. Current smoker or heavy drinker (defined as \>14 drinks per week) or current illicit drug use 11. Currently pregnant, planning to become pregnant, or lactating 12. Concurrent malignancy requiring systemic therapy other than hormonal therapy 13. Cognitively impaired adults

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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