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Can a High-Fiber diet shield the gut during breast cancer therapy?

NCT ID NCT06610097

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether personalized nutrition counseling to increase fiber intake can help preserve the diversity of gut microbes in people undergoing treatment for early-stage triple-negative breast cancer. Participants are randomly assigned to receive either coaching from a registered dietitian or an educational handout alone. Researchers will analyze stool samples to see how diet, activity, and mood affect the gut microbiome during neoadjuvant therapy, and whether a high-fiber diet offers a protective effect.

What this could mean

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

Active substance
personalized nutritional counseling with a registered dietitian to increase fiber intake
What this could lead to
If a high-fiber diet helps preserve gut microbial diversity during treatment, it could point toward a simple, supportive way to improve outcomes and quality of life for breast cancer patients.
What could go wrong
This is a small, early-stage trial, so results may not apply broadly. The intervention is supportive and unlikely to replace standard cancer treatment, and its effect on gut health remains uncertain.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Started

Apr 2025

Finished

Aug 2026

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 to 100 years

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: * Diagnosis of early-stage triple-negative breast cancer, not on neoadjuvant systemic therapy at the time of enrollment. * Age greater than or equal to 18 years and less than 100 years * English proficiency at or above 8th grade level * Expected survival greater than or equal to 12 months Exclusion Criteria: * Prebiotic and/or probiotic use prior to and during the study

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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.

Contacts and locations

Locations

  • Scripps Clinic

    La Jolla, California, 92037, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.