Gut bacteria may fortify bones in breast cancer therapy
NCT ID NCT07044310
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 38 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
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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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Mayo Clinic in Florida
RECRUITINGJacksonville, Florida, 32224-9980, United States
Contact Email: •••••@•••••
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