Probiotics for Abemaciclib-Induced Abdominal Discomfort.

NCT07605728 | Recruiting Phase 2

• 1 other identifier: LL-IRB-2501
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Chemotherapy-induced Diarrhea

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade 2 or Higher Diarrhea

  The primary endpoint is the proportion of patients experiencing Grade 2 or higher diarrhea, defined as an increase of 4 to 6 stools per day from baseline. This measure will compare the incidence between the experimental and control groups across each treatment cycle during the first two months.

  During the first 2 months of the intervention.

Secondary Outcomes (5)

• Abemaciclib Dose Intensity

  4 months

• Loperamide Utilization Rate

  4 months

• Total Duration of Diarrhea

  4 months

• Duration of Grade 2 Diarrhea

  4 months

• Changes in Specific Gut Microbiome-Derived Blood Metabolites

  Baseline, 2 months, and 4 months.

Study Arms (2)

Synbiotic Supplement followed by Placebo

EXPERIMENTAL

Participants in this sequence will receive the synbiotic supplement for the first 2 months, followed by a 2-month period of receiving the placebo. All participants continue their prescribed Abemaciclib therapy. Standard anti-diarrhea medication (Loperamide) is available as needed.

Dietary Supplement: Synbiotic supplement followed by Placebo

Placebo followed by Synbiotic Supplement

PLACEBO COMPARATOR

Participants in this sequence will receive the placebo for the first 2 months, followed by a 2-month period of receiving the synbiotic supplement. All participants continue their prescribed Abemaciclib therapy. Standard anti-diarrhea medication (Loperamide) is available as needed.

Dietary Supplement: Placebo followed by Probiotics

Interventions

Synbiotic supplement followed by Placebo DIETARY_SUPPLEMENT

The synbiotic supplement contains Bifidobacterium longum (probiotics), Oligonol® lychee polyphenol (prebiotics), and functional postbiotics. Participants will take two capsules daily for 2 months during the assigned study phase. This intervention is administered orally to evaluate its efficacy in alleviating Abemaciclib-induced abdominal discomfort.

Synbiotic Supplement followed by Placebo

Placebo followed by Probiotics DIETARY_SUPPLEMENT

Participants in this sequence will receive the placebo for the first 2 months, followed by a 2-month period of receiving the synbiotic supplement (containing Bifidobacterium longum, lychee polyphenol, and postbiotics). All participants continue their prescribed Abemaciclib and endocrine therapy. Standard anti-diarrhea medication (Loperamide) is available as needed.

Placebo followed by Synbiotic Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).
• F. Adequate hepatic function, as defined by:
• Serum alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 3× the upper limit of normal.
• 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.

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• Leeuwenhoek Laboratories Co. Ltd.: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Chiao-Wei Lin

CONTACT

+886-2-2377-2318; cwlin@lwhklab.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 26, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)