Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Gut bacteria may fortify bones in breast cancer therapy

NCT ID NCT07044310

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether a probiotic blend called WBF-038 can prevent bone loss in women with early-stage hormone receptor-positive breast cancer who are about to start aromatase inhibitor therapy. Aromatase inhibitors lower estrogen, which can weaken bones. The study will give participants the probiotic for a year and measure changes in bone turnover and density, along with blood sugar, weight, and waist size, to see if the probiotic helps maintain bone and metabolic health.

What this could mean

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

Active substance
A synbiotic formulation combining prebiotics and five probiotic strains, including Akkermansia muciniphila and Bifidobacterium infantis, designed to improve metabolic and bone health.
What this could lead to
If effective, this probiotic could offer a simple, non-drug way to protect bone health and reduce fracture risk in breast cancer patients on aromatase inhibitors.
What could go wrong
This is a small, early-phase trial, so results may not apply broadly. The probiotic may not significantly slow bone loss, and some people could experience digestive discomfort.

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 38 people

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

Started

Jul 2025

Expected to finish

Jul 2027

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

Female participants only

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: * Female age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Histologically confirmed anatomical stage 0-III hormone receptor-positive breast cancer * Will be starting on an aromatase inhibitor (letrozole, anastrozole, or exemestane) ± ovarian function suppression (OFS) per treating physician's discretion * Absolute neutrophil count (ANC) ≥ 1000/mm\^3 (prior to registration) * Platelet count ≥ 75,000/mm\^3 (prior to registration) * Hemoglobin ≥ 9.0 g/dL (prior to registration) * Creatinine ≤ 2 x upper limit of normal (ULN) (prior to registration) * Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) ≤ 2 x ULN (prior to registration) * Albumin ≥ 3 g/dL (prior to registration) * Willing and able to provide research stool and blood samples * Negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only (\< 60 years old with intact uterus) * Capable of providing valid informed consent * Willing to return to enrolling institution for all study visits (blood draws, etc) Exclusion Criteria: * Requires prolonged systemic antibiotic therapy for other conditions and recent systemic antibiotic ≤ 14 days prior to registration * Fecal microbiota transplant (FMT) ≤ 6 months prior to registration * FMT with an associated serious adverse event related to the FMT product or procedure * Co-morbid systemic illnesses or other severe concurrent diseases which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of over-the-counter probiotics * Immunocompromised patients including patients known to be HIV positive or those on chronic steroids \> 20 mg prednisone a day or prednisone-equivalent. Note: Must be off systemic steroids ≥ 90 days prior to registration. However, topical steroids, inhalants, or steroid eye drops are permitted * History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis * History of chronic diarrhea * History of celiac disease * Currently has a colostomy * Intraabdominal surgery related to gastrointestinal tract ≤ 60 days prior to registration * Evidence of active, severe colitis * History of short gut syndrome or motility disorders * Requires the daily use of medications to manage bowel hypermotility, such as imodium or lomotil * Active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive products) prior to registration. Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment ≤ 30 days prior to registration are not excluded * History of osteoporosis or hyperparathyroidism * History of untreated vitamin D deficiency * Receiving or will receive bisphosphonates during study period (alendronate, risedronate, ibandronate, pamidronate, or zolendronic acid) or denosumab * Patients who received oral bisphosphonate within ≤ 12 weeks, intravenous (IV) zoledronic acid (Reclast) ≤ 52 weeks, or denosumab ≤ 24 weeks will also be excluded * Known hypersensitivity to any component of study product (including known inulin intolerance) * Known hypersensitivity to \> 4 first-line antimicrobial therapies against akkermansia muciniphila, clostridium beijerinckii, clostridium butyricum, anaerobutyricum hallii, including penicillin, piperacillin, tetracycline, amoxicillin, or ampicillin * Known hypersensitivity to \> 4 first line antimicrobial therapies against bifidobacterium infantis Bi-26TM, including gentamicin, kanamycin, streptomycin, tetracycline, erythromycin, clindamycin, ampicillin, vancomycin * Received an experimental product ≤ 30 days prior to registration * Receiving or will receive CDK 4/6 inhibitor (abemaciclib, ribociclib, or palbociclib) * Received chemotherapy ≤ 30 days prior to registration

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Anatomic stage 0 breast cancer ajcc V8 are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224-9980, United States

    Contact Email: •••••@•••••

More trials for these conditions

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