此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Probiotics for Abemaciclib-Induced Abdominal Discomfort.

2026年5月18日 更新者:Leeuwenhoek Laboratories Co. Ltd.

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

80

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Taipei、台湾
        • 招聘中
        • National Taiwan University Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:Synbiotic Supplement followed by Placebo
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.
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.
安慰剂比较:Placebo followed by Synbiotic 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. All participants continue their prescribed Abemaciclib therapy. Standard anti-diarrhea medication (Loperamide) is available as needed.
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of Grade 2 or Higher Diarrhea
大体时间: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.
During the first 2 months of the intervention.

次要结果测量

结果测量
措施说明
大体时间
Abemaciclib Dose Intensity
大体时间:4 months
To compare the total administered dose of Abemaciclib between the synbiotic and placebo groups.
4 months
Loperamide Utilization Rate
大体时间:4 months
The total amount/dosage of standard anti-diarrhea medication (Loperamide) used by participants to manage GI symptoms.
4 months
Total Duration of Diarrhea
大体时间:4 months
The duration of diarrhea (any grade) experienced by participants during the 4-month study period.
4 months
Duration of Grade 2 Diarrhea
大体时间:4 months
The duration of Grade 2 diarrhea experienced by participants.
4 months
Changes in Specific Gut Microbiome-Derived Blood Metabolites
大体时间:Baseline, 2 months, and 4 months.

Evaluation of blood concentration changes in:

  1. Short-Chain Fatty Acids (SCFAs): Acetic, Propionic, Butyric, Isobutyric, Valeric, and Isovaleric acids.
  2. Tryptophan Pathway: Tryptophan, Serotonin, Indole-acetic acid, Indole propionic acid, and Indole-lactic acid.
  3. Bile Acids: Cholic, Chenodeoxycholic, Deoxycholic, and Lithocholic acids.
  4. Uremic and Cardiovascular Toxins: Trimethylamine-N-oxide (TMAO), Indoxyl sulfate, p-cresyl sulfate, and Phenylacetylglutamine.
Baseline, 2 months, and 4 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月15日

初级完成 (估计的)

2029年6月30日

研究完成 (估计的)

2029年12月31日

研究注册日期

首次提交

2026年5月11日

首先提交符合 QC 标准的

2026年5月18日

首次发布 (实际的)

2026年5月26日

研究记录更新

最后更新发布 (实际的)

2026年5月26日

上次提交的符合 QC 标准的更新

2026年5月18日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • LL-IRB-2501

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅