<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/NCT04406129</url>
  </required_header>
  <id_info>
    <org_study_id>2017-GZ10 (Part I)</org_study_id>
    <nct_id>NCT04406129</nct_id>
  </id_info>
  <brief_title>Effect of Gut Microbiome Restoration on Primary Hypertension Via FMT</brief_title>
  <acronym>FMT</acronym>
  <official_title>Effect of Fecal Microbiota Transplantation on Primary Hypertension and the Underlying Mechanism of Gut Microbiome Restoration: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Natural Science Foundation of China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese Academy of Medical Sciences, Fuwai Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mounting preclinical and clinical evidences have proved the causal role of gut microbiota on&#xD;
      the pathogenesis of primary hypertension. Restoration of gut microbiota ameliorated high BP&#xD;
      in rodents and/or human cases.A hypothesis is thus raised that gut microbiome restoration can&#xD;
      be a potential approach to ameliorate hypertension. This pilot study will utilize fecal&#xD;
      microbiota transplantation (FMT) capsules, in comparison with placebo capsules, to&#xD;
      investigate the effect, safety and underlying mechanisms of gut microbiome restoration on&#xD;
      primary hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary hypertension is a most prevalent cardiovascular diseases, and becomes a severe global&#xD;
      public health issue because of the high morbidity and potential risk to other cardiovascular&#xD;
      diseases. Several animal studies and diverse patient cohorts reported that the disorder of&#xD;
      gut microbiome correlated with hypertension. Based on the investigators' previous work&#xD;
      findings of metagenomics analysis, fecal transplantation and metabolomics changes in&#xD;
      hypertension and pre-hypertension patients, a casual role of gut microbiome disorder was&#xD;
      observed in primary hypertension and raised a hypothesis that gut microbiome restoration can&#xD;
      be a potential approach to ameliorate hypertension. Recent studies indicated FMT, prebiotics,&#xD;
      probiotics, dietary changes and other methodologies can assist gut microbiome restoration in&#xD;
      diseases such as type 2 diabetes. The investigators therefore develop two pilot studies&#xD;
      respectively utilizing FMT capsules (Pilot Study I) and innovative dietary changes (Pilot&#xD;
      Study II) to explore the effect, safety and underlying mechanisms of gut microbiome&#xD;
      restoration on hypertension. These pilot studies also present as the clinical translational&#xD;
      section of the research project &quot;The Role of Gut Microbiome in the Pathogenesis of Essential&#xD;
      Hypertension&quot;(Project ID 81630014, sponsored by National Natural Science Foundation of&#xD;
      China).&#xD;
&#xD;
      This study is the Study I:&#xD;
&#xD;
      Objective: To explore the effect, safety and underlying mechanisms of gut microbiome&#xD;
      restoration via FMT on primary hypertension.&#xD;
&#xD;
      Study Design: A multicenter, randomized, double-blinded, placebo-controlled pilot study.&#xD;
&#xD;
      Data quality control and statistical analysis: The investigators have invited professional&#xD;
      statistic analysts to assist analyzing data and a third party to supervise data quality.&#xD;
&#xD;
      Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consents before&#xD;
      patient enrollment are required.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 17, 2021</start_date>
  <completion_date type="Anticipated">September 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2022</primary_completion_date>
  <phase>Early Phase 1</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change for Office Systolic Blood Pressure (SBP)</measure>
    <time_frame>From baseline to Day 30</time_frame>
    <description>Change for Office Systolic Blood Pressure (SBP)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change for Office SBP</measure>
    <time_frame>Baseline, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
    <description>Change for Office SDBP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for Office Diastolic Blood Pressure (DBP)</measure>
    <time_frame>Baseline, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
    <description>Change for Office Diastolic Blood Pressure (DBP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for Home Systolic Blood Pressure (SBP)</measure>
    <time_frame>Baseline, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
    <description>Change for Home Systolic Blood Pressure (SBP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for Home Diastolic Blood Pressure (DBP)</measure>
    <time_frame>Baseline, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
    <description>Change for Home Diastolic Blood Pressure (DBP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for average SBP via 24-hour Ambulatory BP Monitoring</measure>
    <time_frame>Baseline, Day 30, Day 90</time_frame>
    <description>Change for average SBP via 24-hour Ambulatory BP Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for average DBP via 24-hour Ambulatory BP Monitoring</measure>
    <time_frame>Baseline, Day 30, Day 90</time_frame>
    <description>Change for average DBP via 24-hour Ambulatory BP Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for daytime average SBP via 24-hour Ambulatory BP Monitoring</measure>
    <time_frame>Baseline, Day 30, Day 90</time_frame>
    <description>Change for daytime average SBP via 24-hour Ambulatory BP Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for daytime average DBP via 24-hour Ambulatory BP Monitoring</measure>
    <time_frame>Baseline, Day 30, Day 90</time_frame>
    <description>Change for daytime average DBP via 24-hour Ambulatory BP Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for nightime average SBP via 24-hour Ambulatory BP Monitoring</measure>
    <time_frame>Baseline, Day 30, Day 90</time_frame>
    <description>Change for nightime average SBP via 24-hour Ambulatory BP Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for nightime average DBP via 24-hour Ambulatory BP Monitoring</measure>
    <time_frame>Baseline, Day 30, Day 90</time_frame>
    <description>Change for nightime average DBP via 24-hour Ambulatory BP Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for Ankle-Brachial Blood Pressure Index(ABI)</measure>
    <time_frame>Baseline, Day 90</time_frame>
    <description>Change for ABI as an objective measurement of arterial insufficiency based on the ratio of ankle systolic pressure to brachial systolic pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events (AEs) as a Measure of Safety</measure>
    <time_frame>All AEs over 3 months</time_frame>
    <description>Number of Participants with Adverse Events (AEs) as a Measure of Safety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Intestinal Microbiota Composition Pre- and Post-intervention via Metagenomic Analysis</measure>
    <time_frame>Baseline, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
    <description>Changes in Intestinal Microbiota Composition Pre- and Post-intervention (FMT or Placebo) via Metagenomic Analysis, stratified by:&#xD;
Randomisation&#xD;
Change in Office SBP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Intestinal Microbiota Function Pre- and Post-intervention via Metagenomic Analysis</measure>
    <time_frame>Baseline, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
    <description>Changes in Intestinal Microbiota Function Pre- and Post-intervention (FMT or Placebo) via Metagenomic Analysis, stratified by:&#xD;
Randomisation&#xD;
Change in Office SBP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Durability of Engraftment of Donor Microbiome Following FMT</measure>
    <time_frame>Baseline, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
    <description>Durability of engraftment of donor microbiome following FMT, measured by similarity comparison of intestinal microbiota composition between donor and recipient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Intestinal Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis</measure>
    <time_frame>Baseline, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
    <description>Changes in Intestinal Metabolite Composition Pre- and Post-intervention (FMT or Placebo) via Metabolomic Analysis, stratified by:&#xD;
Randomisation&#xD;
Change in Office SBP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Serum Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis</measure>
    <time_frame>Baseline, Day 7, Day 14, Day 30, Day 60, Day 90</time_frame>
    <description>Changes in Serum Metabolite Composition Pre- and Post-intervention (FMT or Placebo) via Metabolomic Analysis, stratified by:&#xD;
Randomisation&#xD;
Change in Office SBP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for Fasting Blood Glucose Level</measure>
    <time_frame>Baseline, Day 90</time_frame>
    <description>Change for Fasting Blood Glucose Level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)</measure>
    <time_frame>Baseline, Day 90</time_frame>
    <description>Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change for Body Mass Index</measure>
    <time_frame>Baseline, Day 90</time_frame>
    <description>Change for Body Mass Index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>FMT capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: FMT capsules containing extensively screened donor stool. FMT capsules will be orally taken on Day 1, Day 7 (Week 1) and Day 14 (Week 2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo capsules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intervention: Placebo capsules that do not contain donor stool or any active drug. Placebo capsules will be orally taken on Day 1, Day 7 (Week 1) and Day 14 (Week 2).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FMT capsules</intervention_name>
    <description>Intervention: FMT capsules containing extensively screened donor stool.</description>
    <arm_group_label>FMT capsules</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo capsules</intervention_name>
    <description>Intervention: Placebo capsules that do not contain donor stool or any active drug.</description>
    <arm_group_label>Placebo capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18~60 years.&#xD;
&#xD;
          2. Established Diagnosis of Grade 1 Hypertension (initial diagnosis or free from&#xD;
             antihypertensive drugs within a month): 140mmHg≤ Office SBP&lt;160mmHg for three&#xD;
             measurements at different days without any antihypertensive medications, according to&#xD;
             the &quot;2010 Chinese Guidelines for Prevention and Treatment of Hypertension&quot;.&#xD;
&#xD;
          3. Patients with informed consent after thorough explanation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Antibiotics or probiotics usage within last 4 weeks&#xD;
&#xD;
          2. Participants of other clinical trials related to hypertension currently or within last&#xD;
             3 months&#xD;
&#xD;
          3. Antihypertensive medications usage currently or within last month&#xD;
&#xD;
          4. Diagnosed secondary hypertension&#xD;
&#xD;
          5. Severe hepatic or renal diseases ((ALT &gt;3 times the upper limit of normal value, or&#xD;
             end stage renal disease on dialysis or eGFR &lt;30 mL/min/1.73 m2, or serum creatinine&#xD;
             &gt;2.5 mg/dl [&gt;221 μmol/L])&#xD;
&#xD;
          6. History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not&#xD;
             including lacunar infarction and transient ischemic attack [TIA])&#xD;
&#xD;
          7. Hospitalization for myocardial infarction within last 6 months; Coronary&#xD;
             revascularization (PCI or CABG) within last 12 months; Planned for PCI or CABG in the&#xD;
             next 12 months.&#xD;
&#xD;
          8. Sustained atrial fibrillation or arrhythmias at recruitment disturbing the electronic&#xD;
             BP measurement.&#xD;
&#xD;
          9. NYHA class III-IV heart failure; Hospitalization for chronic heart failure&#xD;
             exacerbation within last 6 months.&#xD;
&#xD;
         10. Severe valvular diseases; Potential for surgery or percutaneous valve replacement&#xD;
             within the study period.&#xD;
&#xD;
         11. Dilated cardiomyopathy; Hypertrophic cardiomyopathy; Rheumatic heart disease;&#xD;
             Congenital heart disease.&#xD;
&#xD;
         12. Other severe diseases influencing the entry or survival of participants, such as&#xD;
             malignant tumor or acquired immune deficiency syndrome.&#xD;
&#xD;
         13. Cognitive impairment or severe neuropsychiatric comorbidities who are incapable of&#xD;
             providing their own informed consent.&#xD;
&#xD;
         14. Participants preparing for or under pregnancy and/or lactation.&#xD;
&#xD;
         15. Other conditions inappropriate for recruitment according to the investigators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun Cai, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>LUYUN FAN</last_name>
    <phone>01088392165</phone>
    <email>fuwai_fanluyun@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>LU WANG</last_name>
    <phone>01088392165</phone>
    <email>wanglu@fuwai.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fuwai Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jun Cai</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Shantou University</name>
      <address>
        <city>Shantou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Youren Chen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peili Bu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanxi Bethune Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jie Ren</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Southern University of Science and Technology Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Shenzhen</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bingpo Zhu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The People's Hospital of Ji Xian District</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jinfeng Yang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fuwai Yunnan Cardiovascular Hospital</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zihong Guo</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Li J, Zhao F, Wang Y, Chen J, Tao J, Tian G, Wu S, Liu W, Cui Q, Geng B, Zhang W, Weldon R, Auguste K, Yang L, Liu X, Chen L, Yang X, Zhu B, Cai J. Gut microbiota dysbiosis contributes to the development of hypertension. Microbiome. 2017 Feb 1;5(1):14. doi: 10.1186/s40168-016-0222-x.</citation>
    <PMID>28143587</PMID>
  </reference>
  <reference>
    <citation>Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13.</citation>
    <PMID>28087657</PMID>
  </reference>
  <reference>
    <citation>Translating Microbiome Research into Therapies: The Path Ahead. Cell. 2020 Apr 2;181(1):20-21. doi: 10.1016/j.cell.2020.03.009. No abstract available.</citation>
    <PMID>32243790</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>July 10, 2021</last_update_submitted>
  <last_update_submitted_qc>July 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
    <investigator_full_name>Jun Cai</investigator_full_name>
    <investigator_title>Professor, Director of Hypertension Center</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Microbiome</keyword>
  <keyword>Treatment</keyword>
  <keyword>Fecal Microbiota Transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Essential Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT04406129
org study id: 2017-GZ10 (Part I)
nct id: NCT04406129
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Mounting preclinical and clinical evidences have proved the causal role of gut microbiota on
      the pathogenesis of primary hypertension. Restoration of gut microbiota ameliorated high BP
      in rodents and/or human cases.A hypothesis is thus raised that gut microbiome restoration can
      be a potential approach to ameliorate hypertension. This pilot study will utilize fecal
      microbiota transplantation (FMT) capsules, in comparison with placebo capsules, to
      investigate the effect, safety and underlying mechanisms of gut microbiome restoration on
      primary hypertension.
Primary hypertension is a most prevalent cardiovascular diseases, and becomes a severe global
      public health issue because of the high morbidity and potential risk to other cardiovascular
      diseases. Several animal studies and diverse patient cohorts reported that the disorder of
      gut microbiome correlated with hypertension. Based on the investigators' previous work
      findings of metagenomics analysis, fecal transplantation and metabolomics changes in
      hypertension and pre-hypertension patients, a casual role of gut microbiome disorder was
      observed in primary hypertension and raised a hypothesis that gut microbiome restoration can
      be a potential approach to ameliorate hypertension. Recent studies indicated FMT, prebiotics,
      probiotics, dietary changes and other methodologies can assist gut microbiome restoration in
      diseases such as type 2 diabetes. The investigators therefore develop two pilot studies
      respectively utilizing FMT capsules (Pilot Study I) and innovative dietary changes (Pilot
      Study II) to explore the effect, safety and underlying mechanisms of gut microbiome
      restoration on hypertension. These pilot studies also present as the clinical translational
      section of the research project "The Role of Gut Microbiome in the Pathogenesis of Essential
      Hypertension"(Project ID 81630014, sponsored by National Natural Science Foundation of
      China).

      This study is the Study I:

      Objective: To explore the effect, safety and underlying mechanisms of gut microbiome
      restoration via FMT on primary hypertension.

      Study Design: A multicenter, randomized, double-blinded, placebo-controlled pilot study.

      Data quality control and statistical analysis: The investigators have invited professional
      statistic analysts to assist analyzing data and a third party to supervise data quality.

      Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consents before
      patient enrollment are required.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change for Office Systolic Blood Pressure (SBP)
time frame: From baseline to Day 30
description: Change for Office Systolic Blood Pressure (SBP)
measure: Change for Office SBP
time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
description: Change for Office SDBP
measure: Change for Office Diastolic Blood Pressure (DBP)
time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
description: Change for Office Diastolic Blood Pressure (DBP)
measure: Change for Home Systolic Blood Pressure (SBP)
time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
description: Change for Home Systolic Blood Pressure (SBP)
measure: Change for Home Diastolic Blood Pressure (DBP)
time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
description: Change for Home Diastolic Blood Pressure (DBP)
measure: Change for average SBP via 24-hour Ambulatory BP Monitoring
time frame: Baseline, Day 30, Day 90
description: Change for average SBP via 24-hour Ambulatory BP Monitoring
measure: Change for average DBP via 24-hour Ambulatory BP Monitoring
time frame: Baseline, Day 30, Day 90
description: Change for average DBP via 24-hour Ambulatory BP Monitoring
measure: Change for daytime average SBP via 24-hour Ambulatory BP Monitoring
time frame: Baseline, Day 30, Day 90
description: Change for daytime average SBP via 24-hour Ambulatory BP Monitoring
measure: Change for daytime average DBP via 24-hour Ambulatory BP Monitoring
time frame: Baseline, Day 30, Day 90
description: Change for daytime average DBP via 24-hour Ambulatory BP Monitoring
measure: Change for nightime average SBP via 24-hour Ambulatory BP Monitoring
time frame: Baseline, Day 30, Day 90
description: Change for nightime average SBP via 24-hour Ambulatory BP Monitoring
measure: Change for nightime average DBP via 24-hour Ambulatory BP Monitoring
time frame: Baseline, Day 30, Day 90
description: Change for nightime average DBP via 24-hour Ambulatory BP Monitoring
measure: Change for Ankle-Brachial Blood Pressure Index(ABI)
time frame: Baseline, Day 90
description: Change for ABI as an objective measurement of arterial insufficiency based on the ratio of ankle systolic pressure to brachial systolic pressure.
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety
time frame: All AEs over 3 months
description: Number of Participants with Adverse Events (AEs) as a Measure of Safety
measure: Changes in Intestinal Microbiota Composition Pre- and Post-intervention via Metagenomic Analysis
time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
description: Changes in Intestinal Microbiota Composition Pre- and Post-intervention (FMT or Placebo) via Metagenomic Analysis, stratified by:
Randomisation
Change in Office SBP
measure: Changes in Intestinal Microbiota Function Pre- and Post-intervention via Metagenomic Analysis
time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
description: Changes in Intestinal Microbiota Function Pre- and Post-intervention (FMT or Placebo) via Metagenomic Analysis, stratified by:
Randomisation
Change in Office SBP
measure: Durability of Engraftment of Donor Microbiome Following FMT
time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
description: Durability of engraftment of donor microbiome following FMT, measured by similarity comparison of intestinal microbiota composition between donor and recipient
measure: Changes in Intestinal Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis
time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
description: Changes in Intestinal Metabolite Composition Pre- and Post-intervention (FMT or Placebo) via Metabolomic Analysis, stratified by:
Randomisation
Change in Office SBP
measure: Changes in Serum Metabolite Composition Pre- and Post-intervention via Metabolomic Analysis
time frame: Baseline, Day 7, Day 14, Day 30, Day 60, Day 90
description: Changes in Serum Metabolite Composition Pre- and Post-intervention (FMT or Placebo) via Metabolomic Analysis, stratified by:
Randomisation
Change in Office SBP
measure: Change for Fasting Blood Glucose Level
time frame: Baseline, Day 90
description: Change for Fasting Blood Glucose Level
measure: Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)
time frame: Baseline, Day 90
description: Change for Blood Lipid Level (Total Cholesterol, Total Triglyceride, Low Density Lipoprotein Cholesterol, High Density Lipoprotein Cholesterol)
measure: Change for Body Mass Index
time frame: Baseline, Day 90
description: Change for Body Mass Index
arm group label: FMT capsules
arm group type: Experimental
description: Intervention: FMT capsules containing extensively screened donor stool. FMT capsules will be orally taken on Day 1, Day 7 (Week 1) and Day 14 (Week 2).
arm group label: Placebo capsules
arm group type: Placebo Comparator
description: Intervention: Placebo capsules that do not contain donor stool or any active drug. Placebo capsules will be orally taken on Day 1, Day 7 (Week 1) and Day 14 (Week 2).
intervention type: Biological
intervention name: FMT capsules
description: Intervention: FMT capsules containing extensively screened donor stool.
arm group label: FMT capsules
intervention type: Other
intervention name: Placebo capsules
description: Intervention: Placebo capsules that do not contain donor stool or any active drug.
arm group label: Placebo capsules
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jun Cai, MD,PhD
role: Principal Investigator
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
last name: LUYUN FAN
phone: 01088392165
email: fuwai_fanluyun@163.com
last name: LU WANG
phone: 01088392165
email: wanglu@fuwai.com
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
citation: Li J, Zhao F, Wang Y, Chen J, Tao J, Tian G, Wu S, Liu W, Cui Q, Geng B, Zhang W, Weldon R, Auguste K, Yang L, Liu X, Chen L, Yang X, Zhu B, Cai J. Gut microbiota dysbiosis contributes to the development of hypertension. Microbiome. 2017 Feb 1;5(1):14. doi: 10.1186/s40168-016-0222-x.
PMID: 28143587
citation: Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13.
PMID: 28087657
citation: Translating Microbiome Research into Therapies: The Path Ahead. Cell. 2020 Apr 2;181(1):20-21. doi: 10.1016/j.cell.2020.03.009. No abstract available.
PMID: 32243790
responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
investigator full name: Jun Cai
investigator title: Professor, Director of Hypertension Center
mesh term: Hypertension
mesh term: Essential Hypertension