<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/NCT03787771</url>
  </required_header>
  <id_info>
    <org_study_id>FMTR</org_study_id>
    <nct_id>NCT03787771</nct_id>
  </id_info>
  <brief_title>The Fecal Microbiota Transplantation Registry</brief_title>
  <official_title>The Fecal Microbiota Transplantation Registry</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>
      The human intestinal microbiota is composed of complex community of 10*13 to 10*14 commensal&#xD;
      microorganisms[1]. Human intestine provides a nutrient-rich habitat for intestinal&#xD;
      microorganism which allows a diverse ecosystem to enhance their host's immune system and&#xD;
      facilitate digestive activities. Numerous researches are investigating the role of gut&#xD;
      microbiota in human homeostasis, which may be related to the pathogenesis of gastrointestinal&#xD;
      disease and autoimmune disorder.&#xD;
&#xD;
      Fecal microbiota transplantation (FMT) is defined as infusion of feces from healthy donors to&#xD;
      affected subjects. FMT works by altering the patient's microbiome and it is now recommended&#xD;
      as an effective therapy for Clostridium difficile infection (CDI) not responding to standard&#xD;
      therapies[8]. It has attracted great interest in recent years and many researches are&#xD;
      exploring the FMT's potential role for treating other gastrointestinal disease such as IBD. A&#xD;
      FMT registry is required to explore the relationship between disease prognosis and intestinal&#xD;
      microbiota.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The human intestinal microbiota is composed of complex community of 10*13 to 10*14 commensal&#xD;
      microorganisms[1]. Human intestine provides a nutrient-rich habitat for intestinal&#xD;
      microorganism which allows a diverse ecosystem to enhance their host's immune system and&#xD;
      facilitate digestive activities. Numerous researches are investigating the role of gut&#xD;
      microbiota in human homeostasis, which may be related to the pathogenesis of gastrointestinal&#xD;
      disease and autoimmune disorder. A research using gene-sequencing technique showed an&#xD;
      abnormal microbiota composition such as specific group of Escherichia coli and decreased&#xD;
      diversity of intestinal microbiota in individuals with Inflammatory Bowel Disease (IBD)&#xD;
      [2-4]. These microbiotas may stimulate the production of cytokine and chemokines that leads&#xD;
      to the mucosal inflammatory activity[5]. Gut microbiota may also link with the development of&#xD;
      obesity and diabetes by affecting host fat storage and increasing energy harvest from the&#xD;
      diet[6-7].&#xD;
&#xD;
      Fecal microbiota transplantation (FMT) is defined as infusion of feces from healthy donors to&#xD;
      affected subjects. FMT works by altering the patient's microbiome and it is now recommended&#xD;
      as an effective therapy for Clostridium difficile infection (CDI) not responding to standard&#xD;
      therapies8. It has attracted great interest in recent years and many researches are exploring&#xD;
      the FMT's potential role for treating other gastrointestinal disease such as IBD. A recent&#xD;
      clinical study evaluated the efficacy of FMT in active Ulcerative Colitis. It showed&#xD;
      one-forth cases of the FMT group were in UC remission and an increase in diversity of&#xD;
      microbiota composition. However, these results were dependent on the donor[9].&#xD;
&#xD;
      There will be increasing use of FMT in clinical practice, as well as more studies&#xD;
      investigating the effectiveness of FMT on other diseases in the future. However, as an&#xD;
      emerging procedure, there is currently no registry system to track patient safety information&#xD;
      of FMT. It is also equally important to promote scientific investigation around gut&#xD;
      microbiome. Therefore, the investigators aim to establish a FMT registry platform to collect&#xD;
      clinical data and specimen from FMT recipients and donors. This registry is initiated Hong&#xD;
      Kong, and will be expanded to other part of Asia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 2, 2017</start_date>
  <completion_date type="Anticipated">November 2046</completion_date>
  <primary_completion_date type="Anticipated">May 2046</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Set up a FMT registry</measure>
    <time_frame>10 years</time_frame>
    <description>Set up a registry of FMT to collect data such as demographics, past medical history, surgery, severity of disease indicated for FMT cases</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient outcome of FMT</measure>
    <time_frame>10 years</time_frame>
    <description>Compare the severity of disease, any adverse event related to FMT and hospitalization between baseline and FMT. Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factors associated with successful FMT</measure>
    <time_frame>10 years</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>
  <secondary_outcome>
    <measure>Characterize FMT stool donors and other gut-related microbiota products</measure>
    <time_frame>10 years</time_frame>
    <description>Collect study samples to characterize which microbiota favors FMT by metagenomics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FMT in Asia</measure>
    <time_frame>10 years</time_frame>
    <description>Gather information such as the severity of disease, any adverse event related to FMT and hospitalization from other study sites in Asia. Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Promoting scientific investigation in FMT</measure>
    <time_frame>10 years</time_frame>
    <description>Collect study samples to characterize which microbiota favors FMT by metagenomics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Future research studies</measure>
    <time_frame>10 years</time_frame>
    <description>Number of patients who may be eligible for participation in future research studies by collecting their information demographics, past medical history, surgery, severity of disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Developing Biobank of FMT</measure>
    <time_frame>10 years</time_frame>
    <description>Collect and store of study samples from recipients and donors to characterize which microbiota favors FMT by metagenomics</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>FMT recipents</arm_group_label>
    <description>Subject who has received or planning to receive FMT or other gut-related microbiota products in routine clinical practice or research</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FMT donors</arm_group_label>
    <description>Subject who has donated stool or planning to donate stool for FMT or production of other gut-related microbiota products in routine clinical practice or research.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        FMT Recipients Subject who has received or planning to receive FMT or other gut-related&#xD;
        microbiota products in routine clinical practice or research&#xD;
&#xD;
        FMT Donors Subject who has donated stool or planning to donate stool for FMT or production&#xD;
        of other gut-related microbiota products in routine clinical practice or research.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  Written informed consent obtained&#xD;
&#xD;
          -  Subject who has received or planning to receive FMT or other gut-related microbiota&#xD;
             products in routine clinical practice or research (FMT recipents)&#xD;
&#xD;
          -  Subject who has donated stool or planning to donate stool for FMT or production of&#xD;
             other gut-related microbiota products in routine clinical practice or research.&#xD;
             Subjects who failed screening will also be recruited. (FMT donors)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age ≤18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Siew Chien Ng, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Siew Chien Ng, PhD</last_name>
    <phone>852-35053996</phone>
    <email>siewchienng@cuhk.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Siew Chien Ng, PhD</last_name>
      <phone>852 - 35053996</phone>
      <email>siewchienng@cuhk.edu.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>May 26, 2023</last_update_submitted>
  <last_update_submitted_qc>May 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2023</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</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/NCT03787771
org study id: FMTR
nct id: NCT03787771
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The human intestinal microbiota is composed of complex community of 10*13 to 10*14 commensal
      microorganisms[1]. Human intestine provides a nutrient-rich habitat for intestinal
      microorganism which allows a diverse ecosystem to enhance their host's immune system and
      facilitate digestive activities. Numerous researches are investigating the role of gut
      microbiota in human homeostasis, which may be related to the pathogenesis of gastrointestinal
      disease and autoimmune disorder.

      Fecal microbiota transplantation (FMT) is defined as infusion of feces from healthy donors to
      affected subjects. FMT works by altering the patient's microbiome and it is now recommended
      as an effective therapy for Clostridium difficile infection (CDI) not responding to standard
      therapies[8]. It has attracted great interest in recent years and many researches are
      exploring the FMT's potential role for treating other gastrointestinal disease such as IBD. A
      FMT registry is required to explore the relationship between disease prognosis and intestinal
      microbiota.
The human intestinal microbiota is composed of complex community of 10*13 to 10*14 commensal
      microorganisms[1]. Human intestine provides a nutrient-rich habitat for intestinal
      microorganism which allows a diverse ecosystem to enhance their host's immune system and
      facilitate digestive activities. Numerous researches are investigating the role of gut
      microbiota in human homeostasis, which may be related to the pathogenesis of gastrointestinal
      disease and autoimmune disorder. A research using gene-sequencing technique showed an
      abnormal microbiota composition such as specific group of Escherichia coli and decreased
      diversity of intestinal microbiota in individuals with Inflammatory Bowel Disease (IBD)
      [2-4]. These microbiotas may stimulate the production of cytokine and chemokines that leads
      to the mucosal inflammatory activity[5]. Gut microbiota may also link with the development of
      obesity and diabetes by affecting host fat storage and increasing energy harvest from the
      diet[6-7].

      Fecal microbiota transplantation (FMT) is defined as infusion of feces from healthy donors to
      affected subjects. FMT works by altering the patient's microbiome and it is now recommended
      as an effective therapy for Clostridium difficile infection (CDI) not responding to standard
      therapies8. It has attracted great interest in recent years and many researches are exploring
      the FMT's potential role for treating other gastrointestinal disease such as IBD. A recent
      clinical study evaluated the efficacy of FMT in active Ulcerative Colitis. It showed
      one-forth cases of the FMT group were in UC remission and an increase in diversity of
      microbiota composition. However, these results were dependent on the donor[9].

      There will be increasing use of FMT in clinical practice, as well as more studies
      investigating the effectiveness of FMT on other diseases in the future. However, as an
      emerging procedure, there is currently no registry system to track patient safety information
      of FMT. It is also equally important to promote scientific investigation around gut
      microbiome. Therefore, the investigators aim to establish a FMT registry platform to collect
      clinical data and specimen from FMT recipients and donors. This registry is initiated Hong
      Kong, and will be expanded to other part of Asia.
observational model: Cohort
time perspective: Other
measure: Set up a FMT registry
time frame: 10 years
description: Set up a registry of FMT to collect data such as demographics, past medical history, surgery, severity of disease indicated for FMT cases
measure: Patient outcome of FMT
time frame: 10 years
description: Compare the severity of disease, any adverse event related to FMT and hospitalization between baseline and FMT. Survey
measure: Factors associated with successful FMT
time frame: 10 years
description: Study samples will collected to characterize which microbiota favors FMT by performing metagenomics of gut microbiome in stool samples
measure: Characterize FMT stool donors and other gut-related microbiota products
time frame: 10 years
description: Collect study samples to characterize which microbiota favors FMT by metagenomics
measure: FMT in Asia
time frame: 10 years
description: Gather information such as the severity of disease, any adverse event related to FMT and hospitalization from other study sites in Asia. Survey
measure: Promoting scientific investigation in FMT
time frame: 10 years
description: Collect study samples to characterize which microbiota favors FMT by metagenomics
measure: Future research studies
time frame: 10 years
description: Number of patients who may be eligible for participation in future research studies by collecting their information demographics, past medical history, surgery, severity of disease
measure: Developing Biobank of FMT
time frame: 10 years
description: Collect and store of study samples from recipients and donors to characterize which microbiota favors FMT by metagenomics
arm group label: FMT recipents
description: Subject who has received or planning to receive FMT or other gut-related microbiota products in routine clinical practice or research
arm group label: FMT donors
description: Subject who has donated stool or planning to donate stool for FMT or production of other gut-related microbiota products in routine clinical practice or research.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Siew Chien Ng, PhD
role: Principal Investigator
affiliation: Chinese University of Hong Kong
last name: Siew Chien Ng, PhD
phone: 852-35053996
email: siewchienng@cuhk.edu.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Siew Chien NG
investigator title: Professor
mesh term: Inflammatory Bowel Diseases