<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/NCT03789461</url>
  </required_header>
  <id_info>
    <org_study_id>FMT-OB study</org_study_id>
    <nct_id>NCT03789461</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects</brief_title>
  <official_title>An Open-label Pilot Study of Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      Obesity is associated with changes in the composition of the intestinal microbiota, and the&#xD;
      obese microbiome appears to be more efficient in harvesting energy from the diet.&#xD;
&#xD;
      Fecal microbiota transplantation (FMT) represents a clinically feasible way to restore the&#xD;
      gut microbial ecology, and has proven to be a breakthrough for the treatment of recurrent&#xD;
      Clostridium difficile infection.&#xD;
&#xD;
      The therapy is generally well tolerated and appeared safe. No clinical studies have assessed&#xD;
      the dosage of FMT in obese subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently, accumulating evidence supports a role of the enteric microbiota in the pathogenesis&#xD;
      of obesity-related insulin resistance. Obesity is associated with changes in the composition&#xD;
      of the intestinal microbiota, and the obese microbiome appears to be more efficient in&#xD;
      harvesting energy from the diet. Colonization of germ-free mice with an 'obese microbiota'&#xD;
      results in a significantly greater increase in total body fat than colonization with a 'lean&#xD;
      microbiota', suggesting gut microbiota as an additional contributing factor to the&#xD;
      pathophysiology of obesity. Obese and lean phenotypes can also be induced in germ-free mice&#xD;
      by transfer of fecal microbiota from human donors. These data have led to the use of&#xD;
      microbiota therapeutics as a potential treatment for metabolic syndrome and obesity.&#xD;
&#xD;
      Fecal microbiota transplantation (FMT) represents a clinically feasible way to restore the&#xD;
      gut microbial ecology, and has proven to be a breakthrough for the treatment of recurrent&#xD;
      Clostridium difficile infection. Furthermore, clinical trials are being conducted to evaluate&#xD;
      its use for other conditions including inflammatory bowel disease, irritable bowel syndrome,&#xD;
      diabetes mellitus, non-alcoholic steatohepatitis and hepatic encephalopathy. Early results in&#xD;
      human have shown that FMT from lean donor when transplanted into subjects with metabolic&#xD;
      syndrome resulted in a significant improvement in insulin sensitivity and an increased in&#xD;
      intestinal microbial diversity, including a distinct increase in butyrate-producing bacterial&#xD;
      strains. The therapy is generally well tolerated and appeared safe. No clinical studies have&#xD;
      assessed the dosage of FMT in obese subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 28, 2018</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of at least 10% reduction in weight</measure>
    <time_frame>6 weeks</time_frame>
    <description>Determine the proportion of at least 10% reduction in weight compared with baseline weight</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects maintaining weight reduction</measure>
    <time_frame>12, 26, 52, 78, 104 weeks</time_frame>
    <description>Proportion of subjects maintaining at least 10% reduction in weight compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects maintaining weight reduction</measure>
    <time_frame>6,12, 26, 52, 78, 104 weeks</time_frame>
    <description>Proportion of subjects maintaining at least 5% reduction in weight compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in waist circumference</measure>
    <time_frame>6,12, 26, 52, 78, 104 weeks</time_frame>
    <description>Changes in waist circumference compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in waist to hip ratio and in total body weight</measure>
    <time_frame>6,12, 26, 52, 78, 104 weeks</time_frame>
    <description>At least 5% decrease in waist to hip ratio and in total body weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in biochemical parameters</measure>
    <time_frame>6 weeks</time_frame>
    <description>Study samples will collected to characterize which microbiota favors FMT by performing metagenomics of gut microbiome in stool samples</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Fecal Microbiota Transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FMT infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fecal Microbiota Transplantation</intervention_name>
    <description>FMT infusion (100-200ml) and Mucosal Microbiota Assessment (To assess the fecal and mucosal microbiota before and after FMT)</description>
    <arm_group_label>Fecal Microbiota Transplantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-75; and&#xD;
&#xD;
          2. BMI ≥28 kg/m^2 and &lt; 45 kg/m^2; and&#xD;
&#xD;
          3. Written informed consent obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current pregnancy&#xD;
&#xD;
          2. Known history or concomitant significant gastrointestinal disorders (including&#xD;
             Inflammatory Bowel Disease, current colorectal cancer)&#xD;
&#xD;
          3. Known history or concomitant significant food allergies&#xD;
&#xD;
          4. Immunosuppressed subjects&#xD;
&#xD;
          5. Known history of severe organ failure (including decompensated cirrhosis), kidney&#xD;
             failure, epilepsy, acquired immunodeficiency syndrome&#xD;
&#xD;
          6. Current active sepsis&#xD;
&#xD;
          7. Known contraindications to oesophago-gastro-duodenoscopy (OGD)&#xD;
&#xD;
          8. Use of probiotic or antibiotics in recent 3 months&#xD;
&#xD;
          9. New drugs in the last three months that can impact on metabolism or body weight&#xD;
&#xD;
         10. Previous gastric or small intestinal surgery that alters gut anatomy such as&#xD;
             fundoplication, gastric resection, gastric bypass, small bowel resection, ileoectomy,&#xD;
             colectomy&#xD;
&#xD;
         11. Patients who have a confirmed current active malignancy or cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Siew NG, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Turnbaugh PJ, Hamady M, Yatsunenko T, Cantarel BL, Duncan A, Ley RE, Sogin ML, Jones WJ, Roe BA, Affourtit JP, Egholm M, Henrissat B, Heath AC, Knight R, Gordon JI. A core gut microbiome in obese and lean twins. Nature. 2009 Jan 22;457(7228):480-4. doi: 10.1038/nature07540. Epub 2008 Nov 30.</citation>
    <PMID>19043404</PMID>
  </reference>
  <reference>
    <citation>Turnbaugh PJ, Ley RE, Mahowald MA, Magrini V, Mardis ER, Gordon JI. An obesity-associated gut microbiome with increased capacity for energy harvest. Nature. 2006 Dec 21;444(7122):1027-31. doi: 10.1038/nature05414.</citation>
    <PMID>17183312</PMID>
  </reference>
  <reference>
    <citation>Ridaura VK, Faith JJ, Rey FE, Cheng J, Duncan AE, Kau AL, Griffin NW, Lombard V, Henrissat B, Bain JR, Muehlbauer MJ, Ilkayeva O, Semenkovich CF, Funai K, Hayashi DK, Lyle BJ, Martini MC, Ursell LK, Clemente JC, Van Treuren W, Walters WA, Knight R, Newgard CB, Heath AC, Gordon JI. Gut microbiota from twins discordant for obesity modulate metabolism in mice. Science. 2013 Sep 6;341(6150):1241214. doi: 10.1126/science.1241214.</citation>
    <PMID>24009397</PMID>
  </reference>
  <reference>
    <citation>Smith MI, Yatsunenko T, Manary MJ, Trehan I, Mkakosya R, Cheng J, Kau AL, Rich SS, Concannon P, Mychaleckyj JC, Liu J, Houpt E, Li JV, Holmes E, Nicholson J, Knights D, Ursell LK, Knight R, Gordon JI. Gut microbiomes of Malawian twin pairs discordant for kwashiorkor. Science. 2013 Feb 1;339(6119):548-54. doi: 10.1126/science.1229000. Epub 2013 Jan 30.</citation>
    <PMID>23363771</PMID>
  </reference>
  <reference>
    <citation>van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.</citation>
    <PMID>23323867</PMID>
  </reference>
  <reference>
    <citation>Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.</citation>
    <PMID>25857665</PMID>
  </reference>
  <reference>
    <citation>Vrieze A, Van Nood E, Holleman F, Salojarvi J, Kootte RS, Bartelsman JF, Dallinga-Thie GM, Ackermans MT, Serlie MJ, Oozeer R, Derrien M, Druesne A, Van Hylckama Vlieg JE, Bloks VW, Groen AK, Heilig HG, Zoetendal EG, Stroes ES, de Vos WM, Hoekstra JB, Nieuwdorp M. Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome. Gastroenterology. 2012 Oct;143(4):913-6.e7. doi: 10.1053/j.gastro.2012.06.031. Epub 2012 Jun 20. Erratum In: Gastroenterology. 2013 Jan;144(1):250.</citation>
    <PMID>22728514</PMID>
  </reference>
  <reference>
    <citation>Kelly CR, Kahn S, Kashyap P, Laine L, Rubin D, Atreja A, Moore T, Wu G. Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook. Gastroenterology. 2015 Jul;149(1):223-37. doi: 10.1053/j.gastro.2015.05.008. Epub 2015 May 15.</citation>
    <PMID>25982290</PMID>
  </reference>
  <reference>
    <citation>Kassam Z, Lee CH, Yuan Y, Hunt RH. Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis. Am J Gastroenterol. 2013 Apr;108(4):500-8. doi: 10.1038/ajg.2013.59. Epub 2013 Mar 19.</citation>
    <PMID>23511459</PMID>
  </reference>
  <reference>
    <citation>Wong SK, Kong AP, Mui WL, So WY, Tsung BY, Yau PY, Chow FC, Ng EK. Laparoscopic bariatric surgery: a five-year review. Hong Kong Med J. 2009 Apr;15(2):100-9.</citation>
    <PMID>19342735</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>February 10, 2022</last_update_submitted>
  <last_update_submitted_qc>February 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Siew Chien NG</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Fecal Microbiota Transplantation</keyword>
  <keyword>FMT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</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/NCT03789461
org study id: FMT-OB study
nct id: NCT03789461
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Obesity is associated with changes in the composition of the intestinal microbiota, and the
      obese microbiome appears to be more efficient in harvesting energy from the diet.

      Fecal microbiota transplantation (FMT) represents a clinically feasible way to restore the
      gut microbial ecology, and has proven to be a breakthrough for the treatment of recurrent
      Clostridium difficile infection.

      The therapy is generally well tolerated and appeared safe. No clinical studies have assessed
      the dosage of FMT in obese subjects.
Recently, accumulating evidence supports a role of the enteric microbiota in the pathogenesis
      of obesity-related insulin resistance. Obesity is associated with changes in the composition
      of the intestinal microbiota, and the obese microbiome appears to be more efficient in
      harvesting energy from the diet. Colonization of germ-free mice with an 'obese microbiota'
      results in a significantly greater increase in total body fat than colonization with a 'lean
      microbiota', suggesting gut microbiota as an additional contributing factor to the
      pathophysiology of obesity. Obese and lean phenotypes can also be induced in germ-free mice
      by transfer of fecal microbiota from human donors. These data have led to the use of
      microbiota therapeutics as a potential treatment for metabolic syndrome and obesity.

      Fecal microbiota transplantation (FMT) represents a clinically feasible way to restore the
      gut microbial ecology, and has proven to be a breakthrough for the treatment of recurrent
      Clostridium difficile infection. Furthermore, clinical trials are being conducted to evaluate
      its use for other conditions including inflammatory bowel disease, irritable bowel syndrome,
      diabetes mellitus, non-alcoholic steatohepatitis and hepatic encephalopathy. Early results in
      human have shown that FMT from lean donor when transplanted into subjects with metabolic
      syndrome resulted in a significant improvement in insulin sensitivity and an increased in
      intestinal microbial diversity, including a distinct increase in butyrate-producing bacterial
      strains. The therapy is generally well tolerated and appeared safe. No clinical studies have
      assessed the dosage of FMT in obese subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of at least 10% reduction in weight
time frame: 6 weeks
description: Determine the proportion of at least 10% reduction in weight compared with baseline weight
measure: Proportion of subjects maintaining weight reduction
time frame: 12, 26, 52, 78, 104 weeks
description: Proportion of subjects maintaining at least 10% reduction in weight compared with baseline
measure: Proportion of subjects maintaining weight reduction
time frame: 6,12, 26, 52, 78, 104 weeks
description: Proportion of subjects maintaining at least 5% reduction in weight compared with baseline
measure: Changes in waist circumference
time frame: 6,12, 26, 52, 78, 104 weeks
description: Changes in waist circumference compared with baseline
measure: Decrease in waist to hip ratio and in total body weight
time frame: 6,12, 26, 52, 78, 104 weeks
description: At least 5% decrease in waist to hip ratio and in total body weight
measure: Change in biochemical parameters
time frame: 6 weeks
description: Study samples will collected to characterize which microbiota favors FMT by performing metagenomics of gut microbiome in stool samples
arm group label: Fecal Microbiota Transplantation
arm group type: Experimental
description: FMT infusion
intervention type: Procedure
intervention name: Fecal Microbiota Transplantation
description: FMT infusion (100-200ml) and Mucosal Microbiota Assessment (To assess the fecal and mucosal microbiota before and after FMT)
arm group label: Fecal Microbiota Transplantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Siew NG, Prof.
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
citation: Turnbaugh PJ, Hamady M, Yatsunenko T, Cantarel BL, Duncan A, Ley RE, Sogin ML, Jones WJ, Roe BA, Affourtit JP, Egholm M, Henrissat B, Heath AC, Knight R, Gordon JI. A core gut microbiome in obese and lean twins. Nature. 2009 Jan 22;457(7228):480-4. doi: 10.1038/nature07540. Epub 2008 Nov 30.
PMID: 19043404
citation: Turnbaugh PJ, Ley RE, Mahowald MA, Magrini V, Mardis ER, Gordon JI. An obesity-associated gut microbiome with increased capacity for energy harvest. Nature. 2006 Dec 21;444(7122):1027-31. doi: 10.1038/nature05414.
PMID: 17183312
citation: Ridaura VK, Faith JJ, Rey FE, Cheng J, Duncan AE, Kau AL, Griffin NW, Lombard V, Henrissat B, Bain JR, Muehlbauer MJ, Ilkayeva O, Semenkovich CF, Funai K, Hayashi DK, Lyle BJ, Martini MC, Ursell LK, Clemente JC, Van Treuren W, Walters WA, Knight R, Newgard CB, Heath AC, Gordon JI. Gut microbiota from twins discordant for obesity modulate metabolism in mice. Science. 2013 Sep 6;341(6150):1241214. doi: 10.1126/science.1241214.
PMID: 24009397
citation: Smith MI, Yatsunenko T, Manary MJ, Trehan I, Mkakosya R, Cheng J, Kau AL, Rich SS, Concannon P, Mychaleckyj JC, Liu J, Houpt E, Li JV, Holmes E, Nicholson J, Knights D, Ursell LK, Knight R, Gordon JI. Gut microbiomes of Malawian twin pairs discordant for kwashiorkor. Science. 2013 Feb 1;339(6119):548-54. doi: 10.1126/science.1229000. Epub 2013 Jan 30.
PMID: 23363771
citation: van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
PMID: 23323867
citation: Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.
PMID: 25857665
citation: Vrieze A, Van Nood E, Holleman F, Salojarvi J, Kootte RS, Bartelsman JF, Dallinga-Thie GM, Ackermans MT, Serlie MJ, Oozeer R, Derrien M, Druesne A, Van Hylckama Vlieg JE, Bloks VW, Groen AK, Heilig HG, Zoetendal EG, Stroes ES, de Vos WM, Hoekstra JB, Nieuwdorp M. Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome. Gastroenterology. 2012 Oct;143(4):913-6.e7. doi: 10.1053/j.gastro.2012.06.031. Epub 2012 Jun 20. Erratum In: Gastroenterology. 2013 Jan;144(1):250.
PMID: 22728514
citation: Kelly CR, Kahn S, Kashyap P, Laine L, Rubin D, Atreja A, Moore T, Wu G. Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook. Gastroenterology. 2015 Jul;149(1):223-37. doi: 10.1053/j.gastro.2015.05.008. Epub 2015 May 15.
PMID: 25982290
citation: Kassam Z, Lee CH, Yuan Y, Hunt RH. Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis. Am J Gastroenterol. 2013 Apr;108(4):500-8. doi: 10.1038/ajg.2013.59. Epub 2013 Mar 19.
PMID: 23511459
citation: Wong SK, Kong AP, Mui WL, So WY, Tsung BY, Yau PY, Chow FC, Ng EK. Laparoscopic bariatric surgery: a five-year review. Hong Kong Med J. 2009 Apr;15(2):100-9.
PMID: 19342735
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Siew Chien NG
investigator title: Professor
mesh term: Weight Loss