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/NCT06039267</url>
    </required_header>
    <id_info>
      <org_study_id>NCR234792</org_study_id>
      <nct_id>NCT06039267</nct_id>
    </id_info>
    <brief_title>Brain Health &amp; the Microbiome</brief_title>
    <acronym>bMicrobiome</acronym>
    <official_title>Brain Health &amp; the Microbiome: A Proof-of-Concept Study in Patients With Mild Cognitive Impairment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>George Washington University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>George Washington University</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>
        The GW SMHS supports research in complementary and integrative approaches to treatment of&#xD;
        sickness and disease and for health promotion. Sometimes, research may involve asking&#xD;
        questions of patients, students, and health providers. In this study, individuals are being&#xD;
        asked to participate in this study as either 1) a healthy volunteer, 2) a person with Mild&#xD;
        Cognitive Impairment (MCI), or 3) a person with early Alzheimer's disease (eAD). We are&#xD;
        trying to learn more about if the gut microbiome (the microbes that live in our digestive&#xD;
        tract) of individuals with eAD, MCI, and healthy controls are altered following lifestyle&#xD;
        changes. This research will provide the pilot data to begin to understand if these changes in&#xD;
        the gut microbiome are beneficial to health and/or may slow or halt the progression of MCI or&#xD;
        early Alzheimer's.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        AD is, in a word, devastating. The massive psychological and physical trauma experienced by&#xD;
        people with dementia and their loved ones is catastrophic and incapable of overestimation. It&#xD;
        is incumbent upon researchers and clinicians to not only better understand the etiology of&#xD;
        this disease, but also to translate this knowledge into actionable evidence to facilitate&#xD;
        clinical care and prevention. The MGBA serves as a major etiological factor, in both cause&#xD;
        and potentiation of the disease process, that possesses great potential for intervention.&#xD;
        Interventions have the greatest opportunity for success earlier in the disease pathogenesis;&#xD;
        therefore, MCI is an ideal target for intervention to prevent progression to AD. To&#xD;
        effectively apply knowledge of this bidirectional relationship, a clearer picture of&#xD;
        dysbiosis relevant to cognitive decline must be identified. The inclusion of HC, MCI, and&#xD;
        early AD allows for the detection of a dose-response relationship, which is one of Bradford&#xD;
        Hill's criteria for causality. 1 This means we will begin to investigate causality (using one&#xD;
        of Hill's eight criteria) in addition to association in this proof-of-concept study.&#xD;
  &#xD;
        Most previous research has been done at too high a phylogenetic level to be truly informative&#xD;
        in terms of interventions-in other words the data is too low resolution. The microbiome field&#xD;
        was launched at the phylum/genus level for many reasons including the need to start somewhere&#xD;
        in such a complex system. To put this in perspective, comparing a genus, such as&#xD;
        Lactobacillus, would be akin to comparing a compilation or average of all species of the&#xD;
        genus Homo: H. sapiens, H. habilis, H. errectus, H. heigelbergensis, H. neanderthalensis, and&#xD;
        H. naledi. The diversity in Homo sapiens alone is staggering. How could we possibly think&#xD;
        this is specific or high resolution enough to be clinically meaningful? Well, the research&#xD;
        has shown that it is not. This coupled with advancements in technology (qPCR to 16S to&#xD;
        shotgun metagenomics) has changed the landscape of the microbiome field. However, such&#xD;
        advanced testing and understanding has yet to make it to the clinic and has largely not been&#xD;
        applied to MCI or AD populations to date.&#xD;
  &#xD;
        The sum of the evidence suggests that restoration of the gut microbiome may serve to prevent,&#xD;
        slow, or even reverse MCI/AD. Whether this entails the use of diet, supplements, medications,&#xD;
        etc. or some combination thereof remains to be discovered. Before an intervention can be&#xD;
        designed, a firm grasp of the specific alterations to the gut microbiome must be identified&#xD;
        using higher resolution than simply genus alone-we must understand species level at least,&#xD;
        ideally strain level in many cases. Once we understand the species-level alterations,&#xD;
        therapeutic interventions may then be implemented to determine the effect size of said&#xD;
        interventions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 25, 2023</start_date>
    <completion_date type="Anticipated">August 24, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 24, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Gut Microbiome Composition</measure>
      <time_frame>3- and 6-months</time_frame>
      <description>To compare the gut microbiomes of patients with early Alzheimer's disease, mild cognitive impairment, and healthy controls using diversity as well as genus, species, and strain level differences in composition (shotgun metagenomics).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gut Microbiome Function</measure>
      <time_frame>3- and 6-months</time_frame>
      <description>To compare the gut microbiomes of patients with early Alzheimer's disease, mild cognitive impairment, and healthy controls using diversity as well as genus, species, and strain level differences in function (shotgun metagenomics).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Document microbiome changes following lifestyle changes in subjects with early Alzheimer's disease, mild cognitive impairment, and healthy controls for future study design.</measure>
      <time_frame>3- and 6-months</time_frame>
      <description>Observationally collect gut microbiome and lifestyle changes to inform the design of a trial to study lifestyle interventions.</description>
    </primary_outcome>
    <other_outcome>
      <measure>Gut Microbiome Diversity (Index)</measure>
      <time_frame>6 months</time_frame>
      <description>Gut microbiome diversity (index) will exhibit a dose-response relationship among subjects with early Alzheimer's disease, mild cognitive impairment, and healthy controls.</description>
    </other_outcome>
    <other_outcome>
      <measure>Gut Microbiome Composition (Shotgun Metagenomics)</measure>
      <time_frame>6 months</time_frame>
      <description>Gut microbiome composition (shotgun metagenomics) will exhibit a dose-response relationship among subjects with early Alzheimer's disease, mild cognitive impairment, and healthy controls.</description>
    </other_outcome>
    <other_outcome>
      <measure>Gut Microbiome Function (Shotgun Metagenomics)</measure>
      <time_frame>6 months</time_frame>
      <description>Gut microbiome function (shotgun metagenomics) will exhibit a dose-response relationship among subjects with early Alzheimer's disease, mild cognitive impairment, and healthy controls.</description>
    </other_outcome>
    <other_outcome>
      <measure>Diet as Effect-Modifier (DietID)</measure>
      <time_frame>6 months</time_frame>
      <description>Implementing dietary changes (DietID) like increasing microbiota accessible carbohydrates (i.e. prebiotic dietary fiber and resistant starches) will modify the relationship between MCI status and gut microbiome composition and function, dependent upon magnitude and regularity of implementation.</description>
    </other_outcome>
    <other_outcome>
      <measure>Physical Activity as Effect-Modifier (Self-report)</measure>
      <time_frame>6 months</time_frame>
      <description>Implementing physical activity changes (self-report) will modify the relationship between MCI status and gut microbiome composition and function, dependent upon magnitude and regularity of implementation.</description>
    </other_outcome>
    <other_outcome>
      <measure>Probiotic as Effect-Modifier (Self-report)</measure>
      <time_frame>6 months</time_frame>
      <description>Taking a personalized probiotic strain (self-report) will modify the relationship between MCI status and gut microbiome composition and function, dependent upon effectiveness of the probiotic and adherence to the probiotic regimen.</description>
    </other_outcome>
    <other_outcome>
      <measure>Bowel Movement Position as Effect-Modifier (Self-report)</measure>
      <time_frame>6 months</time_frame>
      <description>Improving bowel movement position (i.e. from 90° to 35°, self-report) will modify the relationship between MCI status and gut microbiome composition and function, dependent upon regularity of implementation.</description>
    </other_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Mild Cognitive Impairment</condition>
    <condition>Mild Dementia</condition>
    <condition>Alzheimer Disease 1</condition>
    <arm_group>
      <arm_group_label>Healthy Controls</arm_group_label>
      <description>Healthy males and females, ages 50-90</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mild Cognitive Impairment</arm_group_label>
      <description>Males and females with mild cognitive impairment, ages 50-90</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Early Alzheimer's Disease</arm_group_label>
      <description>Males and females with early Alzheimer's disease, ages 50-90</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Gut Microbiome Testing</intervention_name>
      <description>Stool microbiome testing using shotgun metagenomic sequencing</description>
      <arm_group_label>Early Alzheimer's Disease</arm_group_label>
      <arm_group_label>Healthy Controls</arm_group_label>
      <arm_group_label>Mild Cognitive Impairment</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Residents of the greater Washington, DC Metro Area.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 50-90&#xD;
  &#xD;
            -  Early Alzheimer's Disease (eAD)&#xD;
  &#xD;
            -  Mild Cognitive Impairment (MCI)&#xD;
  &#xD;
            -  Healthy Control (no eAD or MCI)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Criteria or pathology that may affect the outcomes of the study or the risk/benefit&#xD;
               ratio as determined by the study team&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>George Washington University School of Medicine &amp; Health Sciences</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20037</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Abdelmohsen Al Qalam</last_name>
        <phone>843-801-2008</phone>
        <email>aalqalam@gwu.edu</email>
      </contact>
      <contact_backup>
        <last_name>Leigh A Frame, PhD, MHS</last_name>
        <phone>202-994-0184</phone>
        <email>leighframe@gwu.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://framecorrlab.smhs.gwu.edu/research/ongoing-research</url>
      <description>Lab Website</description>
    </link>
    <reference>
      <citation>Vogt NM, Kerby RL, Dill-McFarland KA, Harding SJ, Merluzzi AP, Johnson SC, Carlsson CM, Asthana S, Zetterberg H, Blennow K, Bendlin BB, Rey FE. Gut microbiome alterations in Alzheimer's disease. Sci Rep. 2017 Oct 19;7(1):13537. doi: 10.1038/s41598-017-13601-y.</citation>
      <PMID>29051531</PMID>
    </reference>
    <reference>
      <citation>Mezo C, Dokalis N, Mossad O, Staszewski O, Neuber J, Yilmaz B, Schnepf D, de Aguero MG, Ganal-Vonarburg SC, Macpherson AJ, Meyer-Luehmann M, Staeheli P, Blank T, Prinz M, Erny D. Different effects of constitutive and induced microbiota modulation on microglia in a mouse model of Alzheimer's disease. Acta Neuropathol Commun. 2020 Jul 29;8(1):119. doi: 10.1186/s40478-020-00988-5.</citation>
      <PMID>32727612</PMID>
    </reference>
    <reference>
      <citation>Katsinelos T, Doulberis M, Polyzos SA, Papaefthymiou A, Katsinelos P, Kountouras J. Molecular Links Between Alzheimer's Disease and Gastrointestinal Microbiota: Emphasis on Helicobacter pylori Infection Involvement. Curr Mol Med. 2019;20(1):3-12. doi: 10.2174/1566524019666190917125917.</citation>
      <PMID>31530263</PMID>
    </reference>
    <reference>
      <citation>Roe K. An Alternative Explanation for Alzheimer's Disease and Parkinson's Disease Initiation from Specific Antibiotics, Gut Microbiota Dysbiosis and Neurotoxins. Neurochem Res. 2022 Mar;47(3):517-530. doi: 10.1007/s11064-021-03467-y. Epub 2021 Oct 20.</citation>
      <PMID>34669122</PMID>
    </reference>
    <reference>
      <citation>Wang M, Cao J, Gong C, Amakye WK, Yao M, Ren J. Exploring the microbiota-Alzheimer's disease linkage using short-term antibiotic treatment followed by fecal microbiota transplantation. Brain Behav Immun. 2021 Aug;96:227-238. doi: 10.1016/j.bbi.2021.06.003. Epub 2021 Jun 7.</citation>
      <PMID>34111528</PMID>
    </reference>
    <reference>
      <citation>Quigley EMM. Microbiota-Brain-Gut Axis and Neurodegenerative Diseases. Curr Neurol Neurosci Rep. 2017 Oct 17;17(12):94. doi: 10.1007/s11910-017-0802-6.</citation>
      <PMID>29039142</PMID>
    </reference>
    <reference>
      <citation>Martin CR, Osadchiy V, Kalani A, Mayer EA. The Brain-Gut-Microbiome Axis. Cell Mol Gastroenterol Hepatol. 2018 Apr 12;6(2):133-148. doi: 10.1016/j.jcmgh.2018.04.003. eCollection 2018.</citation>
      <PMID>30023410</PMID>
    </reference>
    <reference>
      <citation>Angelucci F, Cechova K, Amlerova J, Hort J. Antibiotics, gut microbiota, and Alzheimer's disease. J Neuroinflammation. 2019 May 22;16(1):108. doi: 10.1186/s12974-019-1494-4.</citation>
      <PMID>31118068</PMID>
    </reference>
    <reference>
      <citation>Doulberis M, Kotronis G, Gialamprinou D, Polyzos SA, Papaefthymiou A, Katsinelos P, Kountouras J. Alzheimer's disease and gastrointestinal microbiota; impact of Helicobacter pylori infection involvement. Int J Neurosci. 2021 Mar;131(3):289-301. doi: 10.1080/00207454.2020.1738432. Epub 2020 Mar 13.</citation>
      <PMID>32125206</PMID>
    </reference>
    <reference>
      <citation>Liu P, Wu L, Peng G, Han Y, Tang R, Ge J, Zhang L, Jia L, Yue S, Zhou K, Li L, Luo B, Wang B. Altered microbiomes distinguish Alzheimer's disease from amnestic mild cognitive impairment and health in a Chinese cohort. Brain Behav Immun. 2019 Aug;80:633-643. doi: 10.1016/j.bbi.2019.05.008. Epub 2019 May 4.</citation>
      <PMID>31063846</PMID>
    </reference>
    <reference>
      <citation>Zhuang ZQ, Shen LL, Li WW, Fu X, Zeng F, Gui L, Lu Y, Cai M, Zhu C, Tan YL, Zheng P, Li HY, Zhu J, Zhou HD, Bu XL, Wang YJ. Gut Microbiota is Altered in Patients with Alzheimer's Disease. J Alzheimers Dis. 2018;63(4):1337-1346. doi: 10.3233/JAD-180176.</citation>
      <PMID>29758946</PMID>
    </reference>
    <reference>
      <citation>Cattaneo A, Cattane N, Galluzzi S, Provasi S, Lopizzo N, Festari C, Ferrari C, Guerra UP, Paghera B, Muscio C, Bianchetti A, Volta GD, Turla M, Cotelli MS, Gennuso M, Prelle A, Zanetti O, Lussignoli G, Mirabile D, Bellandi D, Gentile S, Belotti G, Villani D, Harach T, Bolmont T, Padovani A, Boccardi M, Frisoni GB; INDIA-FBP Group. Association of brain amyloidosis with pro-inflammatory gut bacterial taxa and peripheral inflammation markers in cognitively impaired elderly. Neurobiol Aging. 2017 Jan;49:60-68. doi: 10.1016/j.neurobiolaging.2016.08.019. Epub 2016 Aug 31.</citation>
      <PMID>27776263</PMID>
    </reference>
    <reference>
      <citation>Liu M, Song S, Chen Q, Sun J, Chu W, Zhang Y, Ji F. Gut microbiota mediates cognitive impairment in young mice after multiple neonatal exposures to sevoflurane. Aging (Albany NY). 2021 Jun 28;13(12):16733-16748. doi: 10.18632/aging.203193. Epub 2021 Jun 28.</citation>
      <PMID>34182544</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No plan to share.</ipd_description>
    </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/NCT06039267
  org study id: NCR234792
  nct id: NCT06039267
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The GW SMHS supports research in complementary and integrative approaches to treatment of
        sickness and disease and for health promotion. Sometimes, research may involve asking
        questions of patients, students, and health providers. In this study, individuals are being
        asked to participate in this study as either 1) a healthy volunteer, 2) a person with Mild
        Cognitive Impairment (MCI), or 3) a person with early Alzheimer's disease (eAD). We are
        trying to learn more about if the gut microbiome (the microbes that live in our digestive
        tract) of individuals with eAD, MCI, and healthy controls are altered following lifestyle
        changes. This research will provide the pilot data to begin to understand if these changes in
        the gut microbiome are beneficial to health and/or may slow or halt the progression of MCI or
        early Alzheimer's.
  AD is, in a word, devastating. The massive psychological and physical trauma experienced by
        people with dementia and their loved ones is catastrophic and incapable of overestimation. It
        is incumbent upon researchers and clinicians to not only better understand the etiology of
        this disease, but also to translate this knowledge into actionable evidence to facilitate
        clinical care and prevention. The MGBA serves as a major etiological factor, in both cause
        and potentiation of the disease process, that possesses great potential for intervention.
        Interventions have the greatest opportunity for success earlier in the disease pathogenesis;
        therefore, MCI is an ideal target for intervention to prevent progression to AD. To
        effectively apply knowledge of this bidirectional relationship, a clearer picture of
        dysbiosis relevant to cognitive decline must be identified. The inclusion of HC, MCI, and
        early AD allows for the detection of a dose-response relationship, which is one of Bradford
        Hill's criteria for causality. 1 This means we will begin to investigate causality (using one
        of Hill's eight criteria) in addition to association in this proof-of-concept study.
  
        Most previous research has been done at too high a phylogenetic level to be truly informative
        in terms of interventions-in other words the data is too low resolution. The microbiome field
        was launched at the phylum/genus level for many reasons including the need to start somewhere
        in such a complex system. To put this in perspective, comparing a genus, such as
        Lactobacillus, would be akin to comparing a compilation or average of all species of the
        genus Homo: H. sapiens, H. habilis, H. errectus, H. heigelbergensis, H. neanderthalensis, and
        H. naledi. The diversity in Homo sapiens alone is staggering. How could we possibly think
        this is specific or high resolution enough to be clinically meaningful? Well, the research
        has shown that it is not. This coupled with advancements in technology (qPCR to 16S to
        shotgun metagenomics) has changed the landscape of the microbiome field. However, such
        advanced testing and understanding has yet to make it to the clinic and has largely not been
        applied to MCI or AD populations to date.
  
        The sum of the evidence suggests that restoration of the gut microbiome may serve to prevent,
        slow, or even reverse MCI/AD. Whether this entails the use of diet, supplements, medications,
        etc. or some combination thereof remains to be discovered. Before an intervention can be
        designed, a firm grasp of the specific alterations to the gut microbiome must be identified
        using higher resolution than simply genus alone-we must understand species level at least,
        ideally strain level in many cases. Once we understand the species-level alterations,
        therapeutic interventions may then be implemented to determine the effect size of said
        interventions.
  observational model: Cohort
  time perspective: Prospective
  measure: Gut Microbiome Composition
  time frame: 3- and 6-months
  description: To compare the gut microbiomes of patients with early Alzheimer's disease, mild cognitive impairment, and healthy controls using diversity as well as genus, species, and strain level differences in composition (shotgun metagenomics).
  measure: Gut Microbiome Function
  time frame: 3- and 6-months
  description: To compare the gut microbiomes of patients with early Alzheimer's disease, mild cognitive impairment, and healthy controls using diversity as well as genus, species, and strain level differences in function (shotgun metagenomics).
  measure: Document microbiome changes following lifestyle changes in subjects with early Alzheimer's disease, mild cognitive impairment, and healthy controls for future study design.
  time frame: 3- and 6-months
  description: Observationally collect gut microbiome and lifestyle changes to inform the design of a trial to study lifestyle interventions.
  measure: Gut Microbiome Diversity (Index)
  time frame: 6 months
  description: Gut microbiome diversity (index) will exhibit a dose-response relationship among subjects with early Alzheimer's disease, mild cognitive impairment, and healthy controls.
  measure: Gut Microbiome Composition (Shotgun Metagenomics)
  time frame: 6 months
  description: Gut microbiome composition (shotgun metagenomics) will exhibit a dose-response relationship among subjects with early Alzheimer's disease, mild cognitive impairment, and healthy controls.
  measure: Gut Microbiome Function (Shotgun Metagenomics)
  time frame: 6 months
  description: Gut microbiome function (shotgun metagenomics) will exhibit a dose-response relationship among subjects with early Alzheimer's disease, mild cognitive impairment, and healthy controls.
  measure: Diet as Effect-Modifier (DietID)
  time frame: 6 months
  description: Implementing dietary changes (DietID) like increasing microbiota accessible carbohydrates (i.e. prebiotic dietary fiber and resistant starches) will modify the relationship between MCI status and gut microbiome composition and function, dependent upon magnitude and regularity of implementation.
  measure: Physical Activity as Effect-Modifier (Self-report)
  time frame: 6 months
  description: Implementing physical activity changes (self-report) will modify the relationship between MCI status and gut microbiome composition and function, dependent upon magnitude and regularity of implementation.
  measure: Probiotic as Effect-Modifier (Self-report)
  time frame: 6 months
  description: Taking a personalized probiotic strain (self-report) will modify the relationship between MCI status and gut microbiome composition and function, dependent upon effectiveness of the probiotic and adherence to the probiotic regimen.
  measure: Bowel Movement Position as Effect-Modifier (Self-report)
  time frame: 6 months
  description: Improving bowel movement position (i.e. from 90° to 35°, self-report) will modify the relationship between MCI status and gut microbiome composition and function, dependent upon regularity of implementation.
  arm group label: Healthy Controls
  description: Healthy males and females, ages 50-90
  arm group label: Mild Cognitive Impairment
  description: Males and females with mild cognitive impairment, ages 50-90
  arm group label: Early Alzheimer's Disease
  description: Males and females with early Alzheimer's disease, ages 50-90
  intervention type: Other
  intervention name: Gut Microbiome Testing
  description: Stool microbiome testing using shotgun metagenomic sequencing
  arm group label: Early Alzheimer's Disease
  arm group label: Healthy Controls
  arm group label: Mild Cognitive Impairment
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 90 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  url: https://framecorrlab.smhs.gwu.edu/research/ongoing-research
  description: Lab Website
  citation: Vogt NM, Kerby RL, Dill-McFarland KA, Harding SJ, Merluzzi AP, Johnson SC, Carlsson CM, Asthana S, Zetterberg H, Blennow K, Bendlin BB, Rey FE. Gut microbiome alterations in Alzheimer's disease. Sci Rep. 2017 Oct 19;7(1):13537. doi: 10.1038/s41598-017-13601-y.
  PMID: 29051531
  citation: Mezo C, Dokalis N, Mossad O, Staszewski O, Neuber J, Yilmaz B, Schnepf D, de Aguero MG, Ganal-Vonarburg SC, Macpherson AJ, Meyer-Luehmann M, Staeheli P, Blank T, Prinz M, Erny D. Different effects of constitutive and induced microbiota modulation on microglia in a mouse model of Alzheimer's disease. Acta Neuropathol Commun. 2020 Jul 29;8(1):119. doi: 10.1186/s40478-020-00988-5.
  PMID: 32727612
  citation: Katsinelos T, Doulberis M, Polyzos SA, Papaefthymiou A, Katsinelos P, Kountouras J. Molecular Links Between Alzheimer's Disease and Gastrointestinal Microbiota: Emphasis on Helicobacter pylori Infection Involvement. Curr Mol Med. 2019;20(1):3-12. doi: 10.2174/1566524019666190917125917.
  PMID: 31530263
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  responsible party type: Sponsor
  mesh term: Alzheimer Disease
  mesh term: Cognitive Dysfunction
  sharing ipd: No
  ipd description: No plan to share.