5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss (NCT07044310)
🩺 Plain-English Summary (8th-Grade Level)
This phase II trial tests how well a probiotic, WBF-038, works in preventing bone loss in patients with early-stage hormone receptor-positive breast cancer who are starting treatment with aromatase inhibitors. Aromatase inhibitors are a drug that blocks the activity of an enzyme called aromatase, which the body uses to make estrogen in the ovaries and other tissues. Blocking aromatase lowers the amount of estrogen made by the body, which may stop the growth of cancer cells that need estrogen to grow. Aromatase inhibitors are used to treat some types of breast cancer or to keep it from coming back. Aromatase inhibitors can affect bone health, weight, blood sugar, and waist size. WBF-038 is a combination of both prebiotics and probiotics, designed to improve metabolic health. Giving WBF-038 may improve bone turnover, bone health, blood sugar, weight, and waist circumference in patients with early-stage hormone receptor-positive breast cancer starting on adjuvant endocrine therapy with an aromatase inhibitor.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (25 items).
Location: Mayo Clinic in Florida — Jacksonville, Florida
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Mayo Clinic in Florida — Jacksonville, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.