NCT07605728 Probiotics for Abemaciclib-Induced Abdominal Discomfort.
| NCT ID | NCT07605728 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Leeuwenhoek Laboratories Co. Ltd. |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2026-05-15 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate whether the addition of probiotics can help reduce abdominal discomfort (such as diarrhea) in breast cancer patients receiving Abemaciclib treatment. Abemaciclib is an effective targeted therapy but often causes gastrointestinal side effects. While Loperamide is the standard treatment for diarrhea, this study explores if probiotics can provide additional relief and improve metabolic health.Participants will be randomly assigned to receive either probiotics or a placebo alongside their standard care. The study will monitor the frequency of abdominal symptoms and analyze blood samples to observe changes in metabolic factors.
Eligibility Criteria
Inclusion Criteria: A. Adults with hormone receptor-positive (HR+) early breast cancer were confirmed. B. At least 18 years old at the time of signing the informed consent. C. Candidates for adjuvant endocrine therapy in combination with Abemaciclib (either NHI-reimbursed or self-funded), as determined by the primary treating physician. Prior chemotherapy requirement: Must have completed prior adjuvant chemotherapy at least 21 days before enrollment. All chemotherapy-related toxicities (except alopecia or Grade 2 peripheral neuropathy) must have resolved to ≤ Grade 1. D. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. E. Adequate bone marrow function as defined by: 1. Absolute Neutrophil Count (ANC) ≥ 1,500/μL without G-CSF support within 14 days of enrollment. 2. Platelet count ≥ 100,000/μL. 3. Hemoglobin ≥ 8.0 g/dL (red blood cell transfusion is permitted prior to enrollment). F. Adequate hepatic function, as defined by: 1. Serum alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 3× the upper limit of normal. 2. Total bilirubin (T-bil) ≤ 1.5× the upper limit of normal. G. Willingness to refrain from using any other oral probiotics or prebiotics from the first dose of the study intervention ("Synbiotic Supplement" or placebo) through study completion. H. Ability to communicate with study personnel and willingness to comply with study visits, treatment plans, and other trial regulations. Exclusion Criteria: A. Currently pregnant or breastfeeding. B. Received systemic antibiotic therapy for active viral, bacterial, or fungal infections within 2 weeks before the first dose of the study intervention. C. Severe pre-existing medical conditions that, in the investigator's judgment, preclude participation, including but not limited to the following: 1. Severe renal impairment (e.g., estimated creatinine clearance \< 30 mL/min). 2. Interstitial lung disease. 3. Severe dyspnea at rest or the requirement for oxygen therapy. 4. History of major gastrointestinal surgeries, such as gastrectomy or small bowel resection. 5. Pre-existing Crohn's disease, ulcerative colitis, or other chronic conditions that cause clinically significant diarrhea. D. History of the following cardiovascular conditions: syncope of cardiovascular origin, ventricular arrhythmias of pathological origin (including ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: Patients with atrial fibrillation that is controlled and stable for at least 30 days before randomization are eligible. E. Unwillingness or inability to provide written informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07605728 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07605728 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07605728 currently recruiting?
Yes, NCT07605728 is actively recruiting participants. Contact the research team at cwlin@lwhklab.com.tw for enrollment information.
Where is the NCT07605728 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT07605728 clinical trial?
NCT07605728 is sponsored by Leeuwenhoek Laboratories Co. Ltd.. The trial plans to enroll 80 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.