Probiotic WBF-038 for Bone Health in HR-positive Breast Cancer
This study is testing if a probiotic called WBF-038 can help prevent bone loss in women with early-stage hormone receptor-positive breast cancer. These women are starting treatment with aromatase inhibitors (medicines that lower estrogen to stop cancer growth), which can sometimes affect bone health. The study aims to see how WBF-038 changes a specific marker in your blood related to bone breakdown over 15 months. You may be eligible if you are a woman aged 18 or older with stage 0-III hormone receptor-positive breast cancer and are about to start an aromatase inhibitor. The study plans to enroll 38 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 38 women. It is testing the effects of the drug WBF-038.
- What's involved
- You would undergo blood sample collection, bone mineral density (BMD) tests, and complete questionnaires. You would also take WBF-038 by mouth for 12 months, starting 3 months after beginning aromatase inhibitor therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your bone health markers will be measured at various points, including 90 days after stopping WBF-038, which is 15 months after starting the aromatase inhibitor.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07044310
5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
Recruiting
PHASE2Ages 18+InterventionalSupportive careMayo ClinicInvestigator-initiated
~38 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Mineral Density TestQuestionnaire AdministrationWBF-038
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in C-terminal telopeptide of type 1 collagen (CTx)
Measured over Baseline; 90 days after start of AI therapy (before beginning WBF-038); 14 days after start of WBF-038; 90 days after start of WBF-038; 180 days after start of WBF-038; 365 days after start of WBF-038; 90 days after stopping WBF-038
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Saranya Chumsri, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Change in C-terminal telopeptide of type 1 collagen (CTx)Baseline; 90 days after start of AI therapy (before beginning WBF-038); 14 days after start of WBF-038; 90 days after start of WBF-038; 180 days after start of WBF-038; 365 days after start of WBF-038; 90 days after stopping WBF-038
Assessed by standard lab tests at baseline (at study enrollment/eligibility assessment before any therapy) followed by 6 study visits. Participants receive aromatase Inhibitor (AI) therapy followed by a one-year course of probiotic WBF-038.