<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/NCT03290651</url>
  </required_header>
  <id_info>
    <org_study_id>110181</org_study_id>
    <nct_id>NCT03290651</nct_id>
  </id_info>
  <brief_title>Probiotics and Breast Health</brief_title>
  <official_title>Re-setting the Breast Microbiome to Lower Inflammation and Risk of Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</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>
      Breast cancer remains a major killer of women and despite major advances in care, the role of&#xD;
      'environmental factors' in the disease remain to be well understood. The investigators have&#xD;
      shown that one such factor is the bacteria that inhabit the breast tissue. These bacteria do&#xD;
      not cause infections per se, but can produce low amounts of substances known to be able to&#xD;
      induce cancer. The investigators have found that the bacteria in the breasts of women with&#xD;
      cancer are very different from those found in the breast tissue of healthy women. The&#xD;
      investigators would like to test their theory that taking probiotic lactobacilli by mouth can&#xD;
      lead to these organisms reaching the breast tissue and help to displace the harmful bacteria&#xD;
      and reduce inflammation which has close links to cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Certain bacteria, particularly Gram negatives, are major causes of inflammation. In fact, the&#xD;
      lipopolysaccharides from these bacteria are used in vast numbers of studies to induce&#xD;
      inflammation and study disease. Many cancers are the result of inflammatory processes. Breast&#xD;
      cancer is a major cause of illness and death in women and inflammatory processes are one of&#xD;
      the foci of investigation; however, not yet from the stand point that bacteria in the breast&#xD;
      may be the instigators of cancer development. The investigators were the first in the world&#xD;
      to describe the breast microbiota and show that the bacterial profiles are more pathogenic in&#xD;
      women with cancer than in tissues of healthy controls. This work has been validated by&#xD;
      others. Although this does not prove a cause-and-effect link with breast cancer, such&#xD;
      linkages have been shown in stomach and colon cancers. If researchers assume there is a link,&#xD;
      then how can the inflammatory microbiota be re-set to one that is somehow beneficial and able&#xD;
      to reduce inflammation and potential cancer induction?&#xD;
&#xD;
      The concept of probiotics emerged from the quest to reset the disrupted microbiota of the gut&#xD;
      and upper respiratory tract. This investigational group has led the world in doing the same&#xD;
      in the urogenital tract of women.&#xD;
&#xD;
      The researchers would like to test their theory that taking probiotic lactobacilli by mouth&#xD;
      can lead to these organisms reaching the breast tissue and helping displace the harmful&#xD;
      bacteria and reducing inflammation. A study in Spain has shown that oral intake of probiotic&#xD;
      lactobacilli can not only cure mastitis, but lead to the lactobacilli reaching the milk&#xD;
      glands. Women who breast feed for more than six months (and thereby pass along lactic acid&#xD;
      bacteria to the infant from the breast milk) have a reduced risk of breast cancer.&#xD;
&#xD;
      The investigators hypothesize that the breast microbiome of women at risk of cancer has the&#xD;
      same profile as women with cancer and that oral administration of probiotic lactobacilli can&#xD;
      reset this to one found in healthy women. They also hypothesize the breast tissue of these&#xD;
      at-risk patients is contaminated by environmental toxins.&#xD;
&#xD;
      The project plan is to test the concept of re-setting the breast tissue microbiota in women&#xD;
      at risk of cancer, to one more aligned with health.&#xD;
&#xD;
      Samples will be tested for relative bacterial abundance to determine any shift in bacterial&#xD;
      breast tissue composition by next-generation sequencing and bioinformatics. Samples will also&#xD;
      be tested for inflammatory markers using Luminex technology, and for mercury, arsenic and&#xD;
      pesticides using LC-MS as described in previous studies.&#xD;
&#xD;
      Twenty women at high-risk for breast cancer (See Inclusion Criteria) will be randomized (10&#xD;
      each) to receive either probiotic or placebo, once a day for 90 days. This capsule is&#xD;
      approved in Canada and widely available and contains 2.5 billion CFU viable bacterial cells&#xD;
      of each of the following strains: Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri&#xD;
      RC-14. Both active capsules and placebo will be provided by the manufacturer Chr Hansen&#xD;
      (Denmark). Samples will be collected at t=0 (enrollment), t=1 (end of 90 days) and t=2(30&#xD;
      days post-treatment).&#xD;
&#xD;
      Twenty women will act as healthy controls (See Inclusion Criteria) and will be randomized (10&#xD;
      each) as described above for the high-risk group.&#xD;
&#xD;
      At each time point, samples collected will include:&#xD;
&#xD;
        -  Breast skin swab - a cotton tipped swab with be moistened with sterile water and the&#xD;
           passed over the skin on the breast 10 times.&#xD;
&#xD;
        -  Needle aspirate - a 22-gauge needle into the breast tissue with repeated passage under&#xD;
           suction until aspirate material is identified in the needle hub. This material would&#xD;
           then be placed in normal saline.&#xD;
&#xD;
        -  Nipple aspirate - the participant will be asked to massage their breast from chest wall&#xD;
           to nipple for several minutes as needed. Using a hand-held modified breast pump placed&#xD;
           over the nipple, nipple aspirate fluid will be drawn out and into a capillary tube.&#xD;
&#xD;
        -  Blood draw - one 6mL EDTA plasma tube using standard phlebotomy procedures. Samples will&#xD;
           be analyzed for relative bacterial abundance (next-generation sequencing), inflammatory&#xD;
           markers (Luminex technology).&#xD;
&#xD;
        -  Urine - 100mL sample that will be tested for heavy metals and pesticides using LC-MS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2, 2019</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</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>Double blind randomized, placebo-controlled pilot trial.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in breast microbiota</measure>
    <time_frame>90 days post collection period</time_frame>
    <description>The diversity of the breast microbiota analysed using next-generation sequencing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Testing of inflammatory markers and pollutants</measure>
    <time_frame>90 days post collection period</time_frame>
    <description>Blood samples will be testing by luminex for inflammatory cytokine/chemokine markers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Testing for environmental pollutants - heavy metals.</measure>
    <time_frame>90 days post collection period</time_frame>
    <description>Urine and blood will be tested for heavy metals using LC-MS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Testing for environmental pollutants - pesticides.</measure>
    <time_frame>90 days post collection period</time_frame>
    <description>Urine and blood will be tested for pesticides using LC-MS.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Breast Cancer Female</condition>
  <arm_group>
    <arm_group_label>Probiotic Natural Health Product - RepHresh Pro-B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One capsule contains 2.5 billion CFU of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo. It is the same composition as the active capsule, without the bacteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic Natural Health Product - RepHresh Pro-B</intervention_name>
    <description>Participants will take the probiotic or placebo daily for 90 days.</description>
    <arm_group_label>Probiotic Natural Health Product - RepHresh Pro-B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will take the probiotic or placebo daily for 90 days.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women at high risk of developing breast cancer who have never had breast cancer (≥ 25%&#xD;
             lifetime risk and/or BRCA1 or BRCA2 positive) will be included in the high risk group,&#xD;
             while female family members of cancer patients or friends of patients, as well as&#xD;
             patients to the breast clinic who are seen for other reasons not related to cancer&#xD;
             will be offered participation in the control group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria include: immunosuppression (ongoing high dose steroids,&#xD;
             immunosuppressive condition such as HIV), personal history of breast cancer, patients&#xD;
             declining needle aspiration biopsy or probiotic/placebo treatment, ongoing daily oral&#xD;
             probiotic treatment at time of diagnosis. Patients on chronic or recent (within 2&#xD;
             weeks) antibiotic therapy will also be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregor Reid, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Health Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Muriel Brackstone, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Joseph's Health Care London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph's Health Care</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Arroyo R, Martin V, Maldonado A, Jimenez E, Fernandez L, Rodriguez JM. Treatment of infectious mastitis during lactation: antibiotics versus oral administration of Lactobacilli isolated from breast milk. Clin Infect Dis. 2010 Jun 15;50(12):1551-8. doi: 10.1086/652763.</citation>
    <PMID>20455694</PMID>
  </reference>
  <reference>
    <citation>Urbaniak C, Cummins J, Brackstone M, Macklaim JM, Gloor GB, Baban CK, Scott L, O'Hanlon DM, Burton JP, Francis KP, Tangney M, Reid G. Microbiota of human breast tissue. Appl Environ Microbiol. 2014 May;80(10):3007-14. doi: 10.1128/AEM.00242-14. Epub 2014 Mar 7.</citation>
    <PMID>24610844</PMID>
  </reference>
  <reference>
    <citation>Urbaniak C, Gloor GB, Brackstone M, Scott L, Tangney M, Reid G. The Microbiota of Breast Tissue and Its Association with Breast Cancer. Appl Environ Microbiol. 2016 Jul 29;82(16):5039-48. doi: 10.1128/AEM.01235-16. Print 2016 Aug 15.</citation>
    <PMID>27342554</PMID>
  </reference>
  <reference>
    <citation>Hieken TJ, Chen J, Hoskin TL, Walther-Antonio M, Johnson S, Ramaker S, Xiao J, Radisky DC, Knutson KL, Kalari KR, Yao JZ, Baddour LM, Chia N, Degnim AC. The Microbiome of Aseptically Collected Human Breast Tissue in Benign and Malignant Disease. Sci Rep. 2016 Aug 3;6:30751. doi: 10.1038/srep30751.</citation>
    <PMID>27485780</PMID>
  </reference>
  <reference>
    <citation>Chan AA, Bashir M, Rivas MN, Duvall K, Sieling PA, Pieber TR, Vaishampayan PA, Love SM, Lee DJ. Characterization of the microbiome of nipple aspirate fluid of breast cancer survivors. Sci Rep. 2016 Jun 21;6:28061. doi: 10.1038/srep28061.</citation>
    <PMID>27324944</PMID>
  </reference>
  <reference>
    <citation>Zackular JP, Baxter NT, Iverson KD, Sadler WD, Petrosino JF, Chen GY, Schloss PD. The gut microbiome modulates colon tumorigenesis. mBio. 2013 Nov 5;4(6):e00692-13. doi: 10.1128/mBio.00692-13.</citation>
    <PMID>24194538</PMID>
  </reference>
  <reference>
    <citation>Mira-Pascual L, Cabrera-Rubio R, Ocon S, Costales P, Parra A, Suarez A, Moris F, Rodrigo L, Mira A, Collado MC. Microbial mucosal colonic shifts associated with the development of colorectal cancer reveal the presence of different bacterial and archaeal biomarkers. J Gastroenterol. 2015 Feb;50(2):167-79. doi: 10.1007/s00535-014-0963-x. Epub 2014 May 9.</citation>
    <PMID>24811328</PMID>
  </reference>
  <reference>
    <citation>Sitas F. Twenty five years since the first prospective study by Forman et al. (1991) on Helicobacter pylori and stomach cancer risk. Cancer Epidemiol. 2016 Apr;41:159-64. doi: 10.1016/j.canep.2016.02.002. Epub 2016 Feb 26.</citation>
    <PMID>26922171</PMID>
  </reference>
  <reference>
    <citation>Macklaim JM, Clemente JC, Knight R, Gloor GB, Reid G. Changes in vaginal microbiota following antimicrobial and probiotic therapy. Microb Ecol Health Dis. 2015 Aug 14;26:27799. doi: 10.3402/mehd.v26.27799. eCollection 2015.</citation>
    <PMID>26282697</PMID>
  </reference>
  <reference>
    <citation>Bisanz JE, Enos MK, Mwanga JR, Changalucha J, Burton JP, Gloor GB, Reid G. Randomized open-label pilot study of the influence of probiotics and the gut microbiome on toxic metal levels in Tanzanian pregnant women and school children. mBio. 2014 Oct 7;5(5):e01580-14. doi: 10.1128/mBio.01580-14.</citation>
    <PMID>25293764</PMID>
  </reference>
  <reference>
    <citation>Bisanz JE, Seney S, McMillan A, Vongsa R, Koenig D, Wong L, Dvoracek B, Gloor GB, Sumarah M, Ford B, Herman D, Burton JP, Reid G. A systems biology approach investigating the effect of probiotics on the vaginal microbiome and host responses in a double blind, placebo-controlled clinical trial of post-menopausal women. PLoS One. 2014 Aug 15;9(8):e104511. doi: 10.1371/journal.pone.0104511. eCollection 2014.</citation>
    <PMID>25127240</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Muriel Brackstone</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03290651
org study id: 110181
nct id: NCT03290651
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Breast cancer remains a major killer of women and despite major advances in care, the role of
      'environmental factors' in the disease remain to be well understood. The investigators have
      shown that one such factor is the bacteria that inhabit the breast tissue. These bacteria do
      not cause infections per se, but can produce low amounts of substances known to be able to
      induce cancer. The investigators have found that the bacteria in the breasts of women with
      cancer are very different from those found in the breast tissue of healthy women. The
      investigators would like to test their theory that taking probiotic lactobacilli by mouth can
      lead to these organisms reaching the breast tissue and help to displace the harmful bacteria
      and reduce inflammation which has close links to cancer.
Certain bacteria, particularly Gram negatives, are major causes of inflammation. In fact, the
      lipopolysaccharides from these bacteria are used in vast numbers of studies to induce
      inflammation and study disease. Many cancers are the result of inflammatory processes. Breast
      cancer is a major cause of illness and death in women and inflammatory processes are one of
      the foci of investigation; however, not yet from the stand point that bacteria in the breast
      may be the instigators of cancer development. The investigators were the first in the world
      to describe the breast microbiota and show that the bacterial profiles are more pathogenic in
      women with cancer than in tissues of healthy controls. This work has been validated by
      others. Although this does not prove a cause-and-effect link with breast cancer, such
      linkages have been shown in stomach and colon cancers. If researchers assume there is a link,
      then how can the inflammatory microbiota be re-set to one that is somehow beneficial and able
      to reduce inflammation and potential cancer induction?

      The concept of probiotics emerged from the quest to reset the disrupted microbiota of the gut
      and upper respiratory tract. This investigational group has led the world in doing the same
      in the urogenital tract of women.

      The researchers would like to test their theory that taking probiotic lactobacilli by mouth
      can lead to these organisms reaching the breast tissue and helping displace the harmful
      bacteria and reducing inflammation. A study in Spain has shown that oral intake of probiotic
      lactobacilli can not only cure mastitis, but lead to the lactobacilli reaching the milk
      glands. Women who breast feed for more than six months (and thereby pass along lactic acid
      bacteria to the infant from the breast milk) have a reduced risk of breast cancer.

      The investigators hypothesize that the breast microbiome of women at risk of cancer has the
      same profile as women with cancer and that oral administration of probiotic lactobacilli can
      reset this to one found in healthy women. They also hypothesize the breast tissue of these
      at-risk patients is contaminated by environmental toxins.

      The project plan is to test the concept of re-setting the breast tissue microbiota in women
      at risk of cancer, to one more aligned with health.

      Samples will be tested for relative bacterial abundance to determine any shift in bacterial
      breast tissue composition by next-generation sequencing and bioinformatics. Samples will also
      be tested for inflammatory markers using Luminex technology, and for mercury, arsenic and
      pesticides using LC-MS as described in previous studies.

      Twenty women at high-risk for breast cancer (See Inclusion Criteria) will be randomized (10
      each) to receive either probiotic or placebo, once a day for 90 days. This capsule is
      approved in Canada and widely available and contains 2.5 billion CFU viable bacterial cells
      of each of the following strains: Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri
      RC-14. Both active capsules and placebo will be provided by the manufacturer Chr Hansen
      (Denmark). Samples will be collected at t=0 (enrollment), t=1 (end of 90 days) and t=2(30
      days post-treatment).

      Twenty women will act as healthy controls (See Inclusion Criteria) and will be randomized (10
      each) as described above for the high-risk group.

      At each time point, samples collected will include:

        -  Breast skin swab - a cotton tipped swab with be moistened with sterile water and the
           passed over the skin on the breast 10 times.

        -  Needle aspirate - a 22-gauge needle into the breast tissue with repeated passage under
           suction until aspirate material is identified in the needle hub. This material would
           then be placed in normal saline.

        -  Nipple aspirate - the participant will be asked to massage their breast from chest wall
           to nipple for several minutes as needed. Using a hand-held modified breast pump placed
           over the nipple, nipple aspirate fluid will be drawn out and into a capillary tube.

        -  Blood draw - one 6mL EDTA plasma tube using standard phlebotomy procedures. Samples will
           be analyzed for relative bacterial abundance (next-generation sequencing), inflammatory
           markers (Luminex technology).

        -  Urine - 100mL sample that will be tested for heavy metals and pesticides using LC-MS.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double blind randomized, placebo-controlled pilot trial.
primary purpose: Basic Science
masking: Double (Participant, Care Provider)
measure: Change in breast microbiota
time frame: 90 days post collection period
description: The diversity of the breast microbiota analysed using next-generation sequencing.
measure: Testing of inflammatory markers and pollutants
time frame: 90 days post collection period
description: Blood samples will be testing by luminex for inflammatory cytokine/chemokine markers.
measure: Testing for environmental pollutants - heavy metals.
time frame: 90 days post collection period
description: Urine and blood will be tested for heavy metals using LC-MS.
measure: Testing for environmental pollutants - pesticides.
time frame: 90 days post collection period
description: Urine and blood will be tested for pesticides using LC-MS.
arm group label: Probiotic Natural Health Product - RepHresh Pro-B
arm group type: Experimental
description: One capsule contains 2.5 billion CFU of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo. It is the same composition as the active capsule, without the bacteria.
intervention type: Dietary Supplement
intervention name: Probiotic Natural Health Product - RepHresh Pro-B
description: Participants will take the probiotic or placebo daily for 90 days.
arm group label: Probiotic Natural Health Product - RepHresh Pro-B
intervention type: Dietary Supplement
intervention name: Placebo
description: Participants will take the probiotic or placebo daily for 90 days.
arm group label: Placebo
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gregor Reid, Ph.D.
role: Principal Investigator
affiliation: Lawson Health Research Institute
last name: Muriel Brackstone, M.D.
role: Principal Investigator
affiliation: St. Joseph's Health Care London
facility: 
country: Canada
citation: Arroyo R, Martin V, Maldonado A, Jimenez E, Fernandez L, Rodriguez JM. Treatment of infectious mastitis during lactation: antibiotics versus oral administration of Lactobacilli isolated from breast milk. Clin Infect Dis. 2010 Jun 15;50(12):1551-8. doi: 10.1086/652763.
PMID: 20455694
citation: Urbaniak C, Cummins J, Brackstone M, Macklaim JM, Gloor GB, Baban CK, Scott L, O'Hanlon DM, Burton JP, Francis KP, Tangney M, Reid G. Microbiota of human breast tissue. Appl Environ Microbiol. 2014 May;80(10):3007-14. doi: 10.1128/AEM.00242-14. Epub 2014 Mar 7.
PMID: 24610844
citation: Urbaniak C, Gloor GB, Brackstone M, Scott L, Tangney M, Reid G. The Microbiota of Breast Tissue and Its Association with Breast Cancer. Appl Environ Microbiol. 2016 Jul 29;82(16):5039-48. doi: 10.1128/AEM.01235-16. Print 2016 Aug 15.
PMID: 27342554
citation: Hieken TJ, Chen J, Hoskin TL, Walther-Antonio M, Johnson S, Ramaker S, Xiao J, Radisky DC, Knutson KL, Kalari KR, Yao JZ, Baddour LM, Chia N, Degnim AC. The Microbiome of Aseptically Collected Human Breast Tissue in Benign and Malignant Disease. Sci Rep. 2016 Aug 3;6:30751. doi: 10.1038/srep30751.
PMID: 27485780
citation: Chan AA, Bashir M, Rivas MN, Duvall K, Sieling PA, Pieber TR, Vaishampayan PA, Love SM, Lee DJ. Characterization of the microbiome of nipple aspirate fluid of breast cancer survivors. Sci Rep. 2016 Jun 21;6:28061. doi: 10.1038/srep28061.
PMID: 27324944
citation: Zackular JP, Baxter NT, Iverson KD, Sadler WD, Petrosino JF, Chen GY, Schloss PD. The gut microbiome modulates colon tumorigenesis. mBio. 2013 Nov 5;4(6):e00692-13. doi: 10.1128/mBio.00692-13.
PMID: 24194538
citation: Mira-Pascual L, Cabrera-Rubio R, Ocon S, Costales P, Parra A, Suarez A, Moris F, Rodrigo L, Mira A, Collado MC. Microbial mucosal colonic shifts associated with the development of colorectal cancer reveal the presence of different bacterial and archaeal biomarkers. J Gastroenterol. 2015 Feb;50(2):167-79. doi: 10.1007/s00535-014-0963-x. Epub 2014 May 9.
PMID: 24811328
citation: Sitas F. Twenty five years since the first prospective study by Forman et al. (1991) on Helicobacter pylori and stomach cancer risk. Cancer Epidemiol. 2016 Apr;41:159-64. doi: 10.1016/j.canep.2016.02.002. Epub 2016 Feb 26.
PMID: 26922171
citation: Macklaim JM, Clemente JC, Knight R, Gloor GB, Reid G. Changes in vaginal microbiota following antimicrobial and probiotic therapy. Microb Ecol Health Dis. 2015 Aug 14;26:27799. doi: 10.3402/mehd.v26.27799. eCollection 2015.
PMID: 26282697
citation: Bisanz JE, Enos MK, Mwanga JR, Changalucha J, Burton JP, Gloor GB, Reid G. Randomized open-label pilot study of the influence of probiotics and the gut microbiome on toxic metal levels in Tanzanian pregnant women and school children. mBio. 2014 Oct 7;5(5):e01580-14. doi: 10.1128/mBio.01580-14.
PMID: 25293764
citation: Bisanz JE, Seney S, McMillan A, Vongsa R, Koenig D, Wong L, Dvoracek B, Gloor GB, Sumarah M, Ford B, Herman D, Burton JP, Reid G. A systems biology approach investigating the effect of probiotics on the vaginal microbiome and host responses in a double blind, placebo-controlled clinical trial of post-menopausal women. PLoS One. 2014 Aug 15;9(8):e104511. doi: 10.1371/journal.pone.0104511. eCollection 2014.
PMID: 25127240
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Muriel Brackstone
investigator title: Principal Investigator
sharing ipd: No