Probiotics for Abemaciclib-Induced Abdominal Discomfort.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeeuwenhoek Laboratories Co. Ltd.
About this trial
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
Qualifiers
Absolute Neutrophil Count (ANC) ≥ 1,500/μL without G-CSF support within 14 days of enrollment.
Platelet count ≥ 100,000/μL.
Hemoglobin ≥ 8.0 g/dL (red blood cell transfusion is permitted prior to enrollment).
Serum alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 3× the upper limit of normal.
Disqualifiers
Severe renal impairment (e.g., estimated creatinine clearance < 30 mL/min).
Interstitial lung disease.
Severe dyspnea at rest or the requirement for oxygen therapy.
History of major gastrointestinal surgeries, such as gastrectomy or small bowel resection.
Trial design
Treatments tested in this trial
- Synbiotic supplement followed by Placebo
- Placebo followed by Probiotics
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov