xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06039644</url>
    </required_header>
    <id_info>
      <org_study_id>BC2023</org_study_id>
      <nct_id>NCT06039644</nct_id>
    </id_info>
    <brief_title>To Evaluate the Clinical Efficacy of Probiotics in Patients With the Breast Cancer</brief_title>
    <official_title>To Evaluate the Efficacy of Probiotics in Improvement and Prevention of Chemotherapy Associated Side Effectes in Patients With the Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>GenMont Biotech Incorporation</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Mackay Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>GenMont Biotech Incorporation</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Chemotherapy-associated side-effects would affect therapeutic effect, quality of life, and&#xD;
        cause permanent harm to breast cancer patients. This study is designed to explore after&#xD;
        consumption of probiotics of lactobacillus composite strain powder sachets for 6 months in&#xD;
        breast cancer chemotherapy, and whether the improvement of meliorate the side effects,&#xD;
        further assists patients completing the chemotherapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In 2020, the incidence rate of women's breast cancer in Taiwan was up to 82.1% . The death&#xD;
        rate increased to 16%; in 2021, the ranking rose to no.3, and the death rate grew up to&#xD;
        24.6%. In the decades, breast cancer gradually becomes the dominant malignant women's cancer&#xD;
        in Taiwan. Besides the lumpectomy, chemotherapy is one of the dominant and important&#xD;
        treatments for breast cancer. Beyond the effects of chemotherapy, several side effects rise&#xD;
        up. The most common chemotherapy are anthracyclin drugs (doxorubicin and epirubicin) and&#xD;
        taxane (docetaxel and paclitaxel ). There are common side effects including neutropenia, hair&#xD;
        loss, vomiting, diarrhea, stomatitis, mucositis, peripheral neuropathy, dermatitis,&#xD;
        nephrotoxicity, and hepatotoxicity. Currently, most treatments for chemotherapy-induced side&#xD;
        effects are symptomatic treatment, but there is no good solution to prevent it.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Parallel Assignment, Randomized Controlled Trial</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 24 weeks</measure>
      <time_frame>24 weeks</time_frame>
      <description>The questionnaire will finished to record the side effects, including nausea, vomiting, diarrhea, stomatitis, peripheral neuropathy, skin rashes, and hand-food syndrome before and after the treatment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from 12 weeks in self-record of the FACT-G questionnaire (The Functional Assessment of Cancer Therapy - General; Version 4) at 24 weeks</measure>
      <time_frame>24 weeks</time_frame>
      <description>The FACT-G questionnaire will record the quality of life by subjects at 12-weeks and-24 weeks. There are 4 domains of quality of life will be measured, including physical well-being, social/family well-being, emotional well-being, functional well-being. All domains will sum as total score of 108, and each domain will also evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variability in BMI (Body Mass Index)</measure>
      <time_frame>24 weeks</time_frame>
      <description>BMI will calculated with weight and height combined in kg/m^2. Measured every visit (week 0. 3. 6. 9. 12. 15. 18. 21. 24)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 12 weeks</measure>
      <time_frame>12 weeks</time_frame>
      <description>Blood samples will collected to examine the variation of hs-CRP from baseline at 12 weeks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 24 weeks</measure>
      <time_frame>24 weeks</time_frame>
      <description>Blood samples will collected to examine the variation of hs-CRP from baseline at 24 weeks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 12 weeks</measure>
      <time_frame>12 weeks</time_frame>
      <description>Blood samples will collected to examine the variation of IL-6 from baseline at 12 weeks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 24 weeks</measure>
      <time_frame>24 weeks</time_frame>
      <description>Blood samples will collected to examine the variation of IL-6 from baseline at 24 weeks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 12 weeks</measure>
      <time_frame>12 weeks</time_frame>
      <description>Blood samples will collected to examine the variation of IL-10 from baseline at 12 weeks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 24 weeks</measure>
      <time_frame>24 weeks</time_frame>
      <description>Blood samples will collected to examine the variation of IL-10 from baseline at 24 weeks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 12 weeks</measure>
      <time_frame>12 weeks</time_frame>
      <description>Blood samples will collected to examine the variation of TNF-α from baseline at 12 weeks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 24 weeks</measure>
      <time_frame>24 weeks</time_frame>
      <description>Blood samples will collected to examine the variation of TNF-α from baseline at 24 weeks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in gut microbiome at 12 weeks</measure>
      <time_frame>12 weeks</time_frame>
      <description>Fecal sample will collected to extract DNA from the intestinal microbiota to examine the variations of gut microbiome from baseline at 12 weeks by NGS (Next Generation Sequencing) analysis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in gut microbiome at 24 weeks</measure>
      <time_frame>24 weeks</time_frame>
      <description>Fecal sample will collected to extract DNA from the intestinal microbiota to examine the variations of gut microbiome from baseline at 24 weeks by NGS (Next Generation Sequencing) analysis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variability in levels of ALT (Alanine Aminotransferase) in IU/L</measure>
      <time_frame>24 weeks</time_frame>
      <description>ALT levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variability in levels of AST (Aspartate Aminotransferase) in IU/L</measure>
      <time_frame>24 weeks</time_frame>
      <description>AST levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variability in levels of Creatinine in mg/dL</measure>
      <time_frame>24 weeks</time_frame>
      <description>Creatinine levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variability in levels of Hb (Hemoglobin) in g/dL</measure>
      <time_frame>24 weeks</time_frame>
      <description>Hb levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variability in levels of RBC (Red Blood Cell count) in 10^6/μL</measure>
      <time_frame>24 weeks</time_frame>
      <description>RBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variability in levels of Ht (Hematocrite) in %</measure>
      <time_frame>24 weeks</time_frame>
      <description>Ht levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variability in levels of WBC(White Blood Cell count) in 10^3/μL</measure>
      <time_frame>24 weeks</time_frame>
      <description>WBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variability in levels of MCV (Mean Corpuscular Volume) in fL</measure>
      <time_frame>24 weeks</time_frame>
      <description>MCV levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variability in levels of MCH (Mean Corpuscular Haemoglobin) in Pg</measure>
      <time_frame>24 weeks</time_frame>
      <description>MCH levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variability in levels of MCHC (Mean Corpuscular Haemoglobin Concentration) in g/dL</measure>
      <time_frame>24 weeks</time_frame>
      <description>MCHC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variability in levels of ANC (Absolute Neutrophil Count) in mm^3</measure>
      <time_frame>24 weeks</time_frame>
      <description>Total neutrophils and WBC collected from routine medical records at each visit to calculate ANC levels. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) ANC is calculated as 10 x WBC count in 1000s x (%Segment neutrophils + % bands neutrophils).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Variability in levels of platelet in 10^3/μL</measure>
      <time_frame>24 weeks</time_frame>
      <description>Platelet levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Probiotic group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects received two probiotic sachets per day</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Subjects received two placebo sachets per day</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Probiotic</intervention_name>
      <description>Three-strain probiotic supplement includes Lactobacillus reuteri GMNL-89 (alive), Lactobacillus plantarum GMNL-141 (alive) and Lactobacillus paracasei GMNL-133 (alive).</description>
      <arm_group_label>Probiotic group</arm_group_label>
      <other_name>Test group</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.</description>
      <arm_group_label>Placebo group</arm_group_label>
      <other_name>Control group</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Stage I-III breast patients using anthracycline-based and taxane-based chemotherapy&#xD;
               (not limited before or after chemotherapy/surgery)&#xD;
  &#xD;
            -  BMI &gt; 18 kg/m^2&#xD;
  &#xD;
            -  Age between 20 and 80 years old&#xD;
  &#xD;
            -  Patients judged by physicians to participate in this trial and who are willing&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or lactating female patients&#xD;
  &#xD;
            -  Patients with bariatric surgery, gastrointestinal resections, Crohn's disease, celiac&#xD;
               disease&#xD;
  &#xD;
            -  BMI &lt; 18 kg/m^2&#xD;
  &#xD;
            -  Patient who have severe allergy to soybeans or peanuts&#xD;
  &#xD;
            -  Those who are under 20 years old or over 80 years old&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Po-Sheng Yang, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mackay Memorial Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fang-Kuei Lin, Master</last_name>
      <phone>+886-6-505-2151</phone>
      <phone_ext>326</phone_ext>
      <email>meitung@genmont.com.tw</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Wan-Hua Tsai, PhD</last_name>
      <phone>+886-6-505-2151</phone>
      <phone_ext>322</phone_ext>
      <email>twh@genmont.com.tw</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>probiotics</keyword>
    <keyword>chemotherapy side-effects</keyword>
    <keyword>Breast carcinoma</keyword>
    <keyword>gut microbiot</keyword>
    <keyword>Lactobacillus reuteri</keyword>
    <keyword>Lactobacillus plantarum</keyword>
    <keyword>Lactobacillus paracasei</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06039644
  org study id: BC2023
  nct id: NCT06039644
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Chemotherapy-associated side-effects would affect therapeutic effect, quality of life, and
        cause permanent harm to breast cancer patients. This study is designed to explore after
        consumption of probiotics of lactobacillus composite strain powder sachets for 6 months in
        breast cancer chemotherapy, and whether the improvement of meliorate the side effects,
        further assists patients completing the chemotherapy.
  In 2020, the incidence rate of women's breast cancer in Taiwan was up to 82.1% . The death
        rate increased to 16%; in 2021, the ranking rose to no.3, and the death rate grew up to
        24.6%. In the decades, breast cancer gradually becomes the dominant malignant women's cancer
        in Taiwan. Besides the lumpectomy, chemotherapy is one of the dominant and important
        treatments for breast cancer. Beyond the effects of chemotherapy, several side effects rise
        up. The most common chemotherapy are anthracyclin drugs (doxorubicin and epirubicin) and
        taxane (docetaxel and paclitaxel ). There are common side effects including neutropenia, hair
        loss, vomiting, diarrhea, stomatitis, mucositis, peripheral neuropathy, dermatitis,
        nephrotoxicity, and hepatotoxicity. Currently, most treatments for chemotherapy-induced side
        effects are symptomatic treatment, but there is no good solution to prevent it.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel Assignment, Randomized Controlled Trial
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  measure: Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 24 weeks
  time frame: 24 weeks
  description: The questionnaire will finished to record the side effects, including nausea, vomiting, diarrhea, stomatitis, peripheral neuropathy, skin rashes, and hand-food syndrome before and after the treatment.
  measure: Change from 12 weeks in self-record of the FACT-G questionnaire (The Functional Assessment of Cancer Therapy - General; Version 4) at 24 weeks
  time frame: 24 weeks
  description: The FACT-G questionnaire will record the quality of life by subjects at 12-weeks and-24 weeks. There are 4 domains of quality of life will be measured, including physical well-being, social/family well-being, emotional well-being, functional well-being. All domains will sum as total score of 108, and each domain will also evaluated.
  measure: Variability in BMI (Body Mass Index)
  time frame: 24 weeks
  description: BMI will calculated with weight and height combined in kg/m^2. Measured every visit (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
  measure: Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 12 weeks
  time frame: 12 weeks
  description: Blood samples will collected to examine the variation of hs-CRP from baseline at 12 weeks.
  measure: Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 24 weeks
  time frame: 24 weeks
  description: Blood samples will collected to examine the variation of hs-CRP from baseline at 24 weeks.
  measure: Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 12 weeks
  time frame: 12 weeks
  description: Blood samples will collected to examine the variation of IL-6 from baseline at 12 weeks.
  measure: Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 24 weeks
  time frame: 24 weeks
  description: Blood samples will collected to examine the variation of IL-6 from baseline at 24 weeks.
  measure: Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 12 weeks
  time frame: 12 weeks
  description: Blood samples will collected to examine the variation of IL-10 from baseline at 12 weeks.
  measure: Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 24 weeks
  time frame: 24 weeks
  description: Blood samples will collected to examine the variation of IL-10 from baseline at 24 weeks.
  measure: Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 12 weeks
  time frame: 12 weeks
  description: Blood samples will collected to examine the variation of TNF-α from baseline at 12 weeks.
  measure: Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 24 weeks
  time frame: 24 weeks
  description: Blood samples will collected to examine the variation of TNF-α from baseline at 24 weeks.
  measure: Change from baseline in gut microbiome at 12 weeks
  time frame: 12 weeks
  description: Fecal sample will collected to extract DNA from the intestinal microbiota to examine the variations of gut microbiome from baseline at 12 weeks by NGS (Next Generation Sequencing) analysis.
  measure: Change from baseline in gut microbiome at 24 weeks
  time frame: 24 weeks
  description: Fecal sample will collected to extract DNA from the intestinal microbiota to examine the variations of gut microbiome from baseline at 24 weeks by NGS (Next Generation Sequencing) analysis.
  measure: Variability in levels of ALT (Alanine Aminotransferase) in IU/L
  time frame: 24 weeks
  description: ALT levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
  measure: Variability in levels of AST (Aspartate Aminotransferase) in IU/L
  time frame: 24 weeks
  description: AST levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
  measure: Variability in levels of Creatinine in mg/dL
  time frame: 24 weeks
  description: Creatinine levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
  measure: Variability in levels of Hb (Hemoglobin) in g/dL
  time frame: 24 weeks
  description: Hb levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
  measure: Variability in levels of RBC (Red Blood Cell count) in 10^6/μL
  time frame: 24 weeks
  description: RBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
  measure: Variability in levels of Ht (Hematocrite) in %
  time frame: 24 weeks
  description: Ht levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
  measure: Variability in levels of WBC(White Blood Cell count) in 10^3/μL
  time frame: 24 weeks
  description: WBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
  measure: Variability in levels of MCV (Mean Corpuscular Volume) in fL
  time frame: 24 weeks
  description: MCV levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
  measure: Variability in levels of MCH (Mean Corpuscular Haemoglobin) in Pg
  time frame: 24 weeks
  description: MCH levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
  measure: Variability in levels of MCHC (Mean Corpuscular Haemoglobin Concentration) in g/dL
  time frame: 24 weeks
  description: MCHC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
  measure: Variability in levels of ANC (Absolute Neutrophil Count) in mm^3
  time frame: 24 weeks
  description: Total neutrophils and WBC collected from routine medical records at each visit to calculate ANC levels. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) ANC is calculated as 10 x WBC count in 1000s x (%Segment neutrophils + % bands neutrophils).
  measure: Variability in levels of platelet in 10^3/μL
  time frame: 24 weeks
  description: Platelet levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
  arm group label: Probiotic group
  arm group type: Experimental
  description: Subjects received two probiotic sachets per day
  arm group label: Placebo group
  arm group type: Placebo Comparator
  description: Subjects received two placebo sachets per day
  intervention type: Dietary Supplement
  intervention name: Probiotic
  description: Three-strain probiotic supplement includes Lactobacillus reuteri GMNL-89 (alive), Lactobacillus plantarum GMNL-141 (alive) and Lactobacillus paracasei GMNL-133 (alive).
  arm group label: Probiotic group
  other name: Test group
  intervention type: Other
  intervention name: Placebo
  description: Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.
  arm group label: Placebo group
  other name: Control group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Po-Sheng Yang, MD, PhD
  role: Principal Investigator
  affiliation: Mackay Memorial Hospital
  last name: Fang-Kuei Lin, Master
  phone: +886-6-505-2151
  phone ext: 326
  email: meitung@genmont.com.tw
  last name: Wan-Hua Tsai, PhD
  phone: +886-6-505-2151
  phone ext: 322
  email: twh@genmont.com.tw
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: No