Breast CancerPhase 2NCT07605728
Probiotics for Abemaciclib-Induced Abdominal Discomfort.
A Phase 2 study of Breast Cancer and Chemotherapy-induced Diarrhea, run by Leeuwenhoek Laboratories Co. Ltd. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Chemotherapy-induced Diarrhea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 May 2026to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with hormone receptor-positive (HR+) early breast cancer were confirmed.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 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.
Show all 11Show fewer
- Hemoglobin ≥ 8.0 g/dL (red blood cell transfusion is permitted prior to enrollment).
- 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.
- Ability to communicate with study personnel and willingness to comply with study visits, treatment plans, and other trial regulations.
Who cannot join
- 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.
- 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.
Show all 9Show fewer
- Pre-existing Crohn's disease, ulcerative colitis, or other chronic conditions that cause clinically significant diarrhea.
- 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.
- Unwillingness or inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Wei-Li Ma, +886-2-2312-3456 ext. 263155, excellent0667@gmail.com
About this study
Official title: A Randomized, Phase II Study About Probiotics to Alleviate Abemaciclib-induced Abdominal Discomfort Under Standard Anti-diarrhea Drug Loperamide and Changes of Metabolic Factors in Blood.
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.
Read the detailed description
This study investigates whether a specific "Synbiotic" supplement (containing probiotics, prebiotics, and postbiotics) can help reduce abdominal discomfort, particularly diarrhea, in breast cancer patients taking the targeted therapy drug, Abemaciclib. Abemaciclib is highly effective in preventing breast cancer recurrence but frequently causes gastrointestinal side effects. While standard anti-diarrhea medications (Loperamide) are used, many patients still experience discomfort. Preliminary observations suggest that certain probiotics and polyphenols may help restore intestinal balance and reduce these symptoms. Participants will be randomly assigned to two groups. During the 4-month study period, everyone will receive both the synbiotic supplement and a placebo at different stages (a crossover design). All participants will continue their standard cancer treatment and have access to standard anti-diarrhea medication as needed. The study will also analyze blood samples to see if the supplement improves metabolic health.
- Conditions
- Breast Cancer, Chemotherapy-induced Diarrhea
- Being tested
- Synbiotic supplement followed by Placebo, Placebo followed by Probiotics
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic supplement followed by PlaceboDietary 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.
Placebo followed by ProbioticsDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo followed by Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the first 2 months of the intervention.
Secondary outcomes (5)
Abemaciclib Dose Intensity
To compare the total administered dose of Abemaciclib between the synbiotic and placebo groups.
Measured: 4 months
Loperamide Utilization Rate
The total amount/dosage of standard anti-diarrhea medication (Loperamide) used by participants to manage GI symptoms.
Measured: 4 months
Total Duration of Diarrhea
The duration of diarrhea (any grade) experienced by participants during the 4-month study period.
Measured: 4 months
Duration of Grade 2 Diarrhea
The duration of Grade 2 diarrhea experienced by participants.
Measured: 4 months
Changes in Specific Gut Microbiome-Derived Blood Metabolites
Evaluation of blood concentration changes in:
- Short-Chain Fatty Acids (SCFAs): Acetic, Propionic, Butyric, Isobutyric, Valeric, and Isovaleric acids.
- Tryptophan Pathway: Tryptophan, Serotonin, Indole-acetic acid, Indole propionic acid, and Indole-lactic acid.
- Bile Acids: Cholic, Chenodeoxycholic, Deoxycholic, and Lithocholic acids.
- Uremic and Cardiovascular Toxins: Trimethylamine-N-oxide (TMAO), Indoxyl sulfate, p-cresyl sulfate, and Phenylacetylglutamine.
Measured: Baseline, 2 months, and 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start15 May 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leeuwenhoek Laboratories Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605728
- Sponsor's protocol ID
- LL-IRB-2501
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase II Study About Probiotics to Alleviate Abemaciclib-induced Abdominal Discomfort Under Standard Anti-diarrhea Drug Loperamide and Changes of Metabolic Factors in Blood.
- ClinicalTrials.gov ID
- NCT07605728
- Acronym / sponsor ID
- LL-IRB-2501
- Conditions
- Breast Cancer, Chemotherapy-induced Diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Leeuwenhoek Laboratories Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study investigates whether a specific "Synbiotic" supplement (containing probiotics, prebiotics, and postbiotics) can help reduce abdominal discomfort, particularly diarrhea, in breast cancer patients taking the targeted therapy drug, Abemaciclib. Abemaciclib is highly effective in preventing breast cancer recurrence but frequently causes gastrointestinal side effects. While standard anti-diarrhea medications (Loperamide) are used, many patients still experience discomfort. Preliminary observations suggest that certain probiotics and polyphenols may help restore intestinal balance and reduce these symptoms. Participants will be randomly assigned to two groups. During the 4-month study period, everyone will receive both the synbiotic supplement and a placebo at different stages (a crossover design). All participants will continue their standard cancer treatment and have access to standard anti-diarrhea medication as needed. The study will also analyze blood samples to see if the supplement improves metabolic health.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic Supplement followed by Placebo | Experimental | Dietary Supplement: Synbiotic supplement followed by PlaceboParticipants 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. |
| Placebo followed by Synbiotic Supplement | Placebo comparator | Dietary Supplement: Placebo followed by ProbioticsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults with hormone receptor-positive (HR+) early breast cancer were confirmed.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate bone marrow function as defined by:
- Absolute Neutrophil Count (ANC) ≥ 1,500/μL without G-CSF support within 14 days of enrollment.
Key exclusion criteria (9 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synbiotic supplement followed by PlaceboThe 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. | Dietary supplement | Synbiotic Supplement followed by Placebo |
| Placebo followed by ProbioticsParticipants 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. | Dietary supplement | Placebo followed by Synbiotic Supplement |
Primary outcome
Incidence of Grade 2 or Higher Diarrhea
Time frame: During the first 2 months of the intervention.
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.
5 secondary outcomes
Abemaciclib Dose Intensity
Time frame: 4 months
Loperamide Utilization Rate
Time frame: 4 months
Total Duration of Diarrhea
Time frame: 4 months
Duration of Grade 2 Diarrhea
Time frame: 4 months
Changes in Specific Gut Microbiome-Derived Blood Metabolites
Time frame: Baseline, 2 months, and 4 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
Active, not recruitingObservational study
A ReaL World Study of DS-8201
Breast Cancer Metastatic, Treatment Efficacy
RecruitingPhase 3
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Breast Neoplasms
RecruitingObservational study
Characterization of Extracellular Vesicles in Breast Cancer Patients
Breast Cancer
Not yet recruitingPhase 4
Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
Hormone Therapy-induced Arthralgia, Phytotherapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Breast Cancer and Chemotherapy-induced Diarrhea, run by Leeuwenhoek Laboratories Co. Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiao-Wei Lin (+886-2-2377-2318 ext. 202, cwlin@lwhklab.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 2 or Higher Diarrhea (time frame: During the first 2 months of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.