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/NCT05998213</url>
    </required_header>
    <id_info>
      <org_study_id>NL65069.018.18</org_study_id>
      <nct_id>NCT05998213</nct_id>
    </id_info>
    <brief_title>Transfer of Feces in Ulcerative Colitis 2</brief_title>
    <acronym>TURN2</acronym>
    <official_title>Transfer of Feces in Ulcerative Colitis 2; Improving Efficacy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University Medical Center Groningen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>UMC Utrecht</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of this placebo-controlled randomised multicenter trial is to evaluate the efficacy&#xD;
        and safety of anaerobic prepared donor fecal microbiota transplantation (FMT) compared to&#xD;
        autologous FMT in patient with ulcerative colitis.&#xD;
  &#xD;
        Participants will receive 4 treatments with frozen FMT via both upper and lower&#xD;
        gastro-intestinal route (infusion via duodenal tube and enemas).&#xD;
  &#xD;
        Donors are selected based on microbiota profile.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 5, 2018</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</primary_completion_date>
    <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical and endoscopic remission</measure>
      <time_frame>week 8</time_frame>
      <description>per adapted Mayo: stool frequency subscores (SFS) ≤ 1, rectal bleeding subscore (RBS) =0 and endoscopic subscore ≤ 1.&#xD;
  The adapted Mayo score has a minimum score of 0 and a maximum score of 9. The 3 subscores (SFS, RBS, and endoscopic subscore) have a minimum of 0 and a maximum score of 3. The adapted Mayo score does not include PGA (physician global assessment), in contrary to the full Mayo score. A higher score reflects worse outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical response</measure>
      <time_frame>week 8</time_frame>
      <description>Adapted Mayo: decrease from baseline ≥ 2 points and ≥ 30% plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.&#xD;
  The adapted Mayo score has a minimum score of 0 and a maximum score of 9. The 3 subscores (SFS, RBS, and endoscopic subscore) have a minimum of 0 and a maximum score of 3. The adapted Mayo score does not include PGA (physician global assessment), in contrary to the full Mayo score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Endoscopic response, evaluated by sigmoidoscopy</measure>
      <time_frame>week 8</time_frame>
      <description>•Proportion of patients with ≥1 point reduction in summed endoscopic Mayo score of both the rectum and sigmoid.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">76</enrollment>
    <condition>Ulcerative Colitis</condition>
    <condition>Ulcerative Colitis Flare</condition>
    <condition>Ulcerative Colitis Acute</condition>
    <arm_group>
      <arm_group_label>Donor fecal microbiota transplant</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Autologous fecal microbiota transplant</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Fecal microbiota transplant</intervention_name>
      <description>Frozen FMT via duodenal tube (2 times) and enemas (4 times)</description>
      <arm_group_label>Autologous fecal microbiota transplant</arm_group_label>
      <arm_group_label>Donor fecal microbiota transplant</arm_group_label>
      <other_name>FMT</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 and &lt;70&#xD;
  &#xD;
            -  Ability to give informed consent&#xD;
  &#xD;
            -  Established ulcerative colitis with known involvement of the left colon according to&#xD;
               the Lennard-Jones criteria&#xD;
  &#xD;
            -  Partial mayo score of ≥ 3 and calprotectin &gt; 250&#xD;
  &#xD;
            -  Full Mayo score 5-9&#xD;
  &#xD;
            -  Endoscopic Mayo score of ≥2 in either the rectum or sigmoid upon screening&#xD;
               sigmoidoscopy&#xD;
  &#xD;
            -  Stable dose of thiopurines or , 5-ASA, or budesonide in preceding 8 weeks.&#xD;
  &#xD;
            -  Stable dose of budesonide in preceding 2 weeks.&#xD;
  &#xD;
            -  Prednisone use ≤15mg/day in preceding 2 weeks with a mandatory taper of 5 mg per week&#xD;
               starting from week 4.&#xD;
  &#xD;
            -  Women need to use reliable contraceptives during participation in the study&#xD;
  &#xD;
            -  Alkaline phosphatase &gt; 1.5 x ULN in the subgroup of PSC/UC patients.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Condition leading to profound immunosuppression&#xD;
  &#xD;
                 -  For example: HIV, infectious diseases leading to immunosuppression, bone marrow&#xD;
                    malignancies&#xD;
  &#xD;
                 -  Use of systemic chemotherapy&#xD;
  &#xD;
                 -  Child-Pugh B liver cirrhosis&#xD;
  &#xD;
            -  Anti-TNFα treatment in preceding 2 months&#xD;
  &#xD;
            -  Vedolizumab treatment in preceding 2 months&#xD;
  &#xD;
            -  Tofacitinib treatment in preceding 2 months&#xD;
  &#xD;
            -  Ustekinumab treatment in preceding 2 months&#xD;
  &#xD;
            -  Cyclosporine treatment in preceding 4 weeks&#xD;
  &#xD;
            -  Use of Methotrexate in preceding 2 months&#xD;
  &#xD;
            -  Prednisolone dose &gt; 15 mg/day in preceding 2 weeks&#xD;
  &#xD;
            -  Use of topical therapy in preceding 2 weeks&#xD;
  &#xD;
            -  Life expectancy &lt; 12 months&#xD;
  &#xD;
            -  Difficulty with swallowing&#xD;
  &#xD;
            -  Use of systemic antibiotics in preceding 4 weeks&#xD;
  &#xD;
            -  Use of probiotic treatment in preceding 4 weeks&#xD;
  &#xD;
            -  Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia,&#xD;
               Campylobacter, enteropathogenic e coli)&#xD;
  &#xD;
            -  Positive C. Difficile stool test&#xD;
  &#xD;
            -  Positive dual faeces test for pathogenic parasites e.g. Dientamoeba histolytica,&#xD;
               Giardia Lamblia, Dientamoeba fragilis, Blastocystis hominis only if microscopically&#xD;
               many or very many blastocysts are seen.&#xD;
  &#xD;
            -  Positive serological test for HIV&#xD;
  &#xD;
            -  History of surgery:&#xD;
  &#xD;
                 -  presence of a pouch&#xD;
  &#xD;
                 -  presence of stoma&#xD;
  &#xD;
            -  Known intra-abdominal fistula&#xD;
  &#xD;
            -  Pregnancy or women who give breastfeeding&#xD;
  &#xD;
            -  Vasopressive medication, icu stay&#xD;
  &#xD;
            -  Signs of ileus, diminished passage&#xD;
  &#xD;
            -  Allergy to macrogol or substituents, eg peanuts, shellfish&#xD;
  &#xD;
            -  Known allergy to iv gadolinium in the subgroup of patients who would be scheduled for&#xD;
               MRI liver&#xD;
  &#xD;
            -  Crohn's disease&#xD;
  &#xD;
            -  Subject who has any conditions that in the opinion of the investigator, would&#xD;
               compromise the safety of the subject or the quality of the data and is an unsuitable&#xD;
               candidate for the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Cyriel Ponsioen, prof.</last_name>
      <phone>+31 20 5668278</phone>
      <email>c.y.ponsioen@amsterdamumc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Melanie Benard, Msc</last_name>
      <phone>0031645050314</phone>
      <email>m.v.benard@amsterdamumc.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Amsterdam University Medical Center</name>
        <address>
          <city>Amsterdam</city>
          <state>Noord-Holland</state>
          <zip>1061BK</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Melanie V. Bénard, Msc</last_name>
        <email>m.v.benard@amsterdamumc.nl</email>
      </contact>
      <contact_backup>
        <last_name>Florine Jiwa</last_name>
        <email>f.h.jiwa@amsterdamumc.nl</email>
      </contact_backup>
      <investigator>
        <last_name>Rinse K. Weersma, Prof. dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>Cyriel Y Ponsioen</investigator_full_name>
      <investigator_title>prof. dr.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colitis</mesh_term>
      <mesh_term>Colitis, Ulcerative</mesh_term>
      <mesh_term>Ulcer</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
    </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/NCT05998213
  org study id: NL65069.018.18
  nct id: NCT05998213
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this placebo-controlled randomised multicenter trial is to evaluate the efficacy
        and safety of anaerobic prepared donor fecal microbiota transplantation (FMT) compared to
        autologous FMT in patient with ulcerative colitis.
  
        Participants will receive 4 treatments with frozen FMT via both upper and lower
        gastro-intestinal route (infusion via duodenal tube and enemas).
  
        Donors are selected based on microbiota profile.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Clinical and endoscopic remission
  time frame: week 8
  description: per adapted Mayo: stool frequency subscores (SFS) ≤ 1, rectal bleeding subscore (RBS) =0 and endoscopic subscore ≤ 1.
  The adapted Mayo score has a minimum score of 0 and a maximum score of 9. The 3 subscores (SFS, RBS, and endoscopic subscore) have a minimum of 0 and a maximum score of 3. The adapted Mayo score does not include PGA (physician global assessment), in contrary to the full Mayo score. A higher score reflects worse outcome.
  measure: Clinical response
  time frame: week 8
  description: Adapted Mayo: decrease from baseline ≥ 2 points and ≥ 30% plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
  The adapted Mayo score has a minimum score of 0 and a maximum score of 9. The 3 subscores (SFS, RBS, and endoscopic subscore) have a minimum of 0 and a maximum score of 3. The adapted Mayo score does not include PGA (physician global assessment), in contrary to the full Mayo score.
  measure: Endoscopic response, evaluated by sigmoidoscopy
  time frame: week 8
  description: •Proportion of patients with ≥1 point reduction in summed endoscopic Mayo score of both the rectum and sigmoid.
  arm group label: Donor fecal microbiota transplant
  arm group type: Experimental
  arm group label: Autologous fecal microbiota transplant
  arm group type: Placebo Comparator
  intervention type: Other
  intervention name: Fecal microbiota transplant
  description: Frozen FMT via duodenal tube (2 times) and enemas (4 times)
  arm group label: Autologous fecal microbiota transplant
  arm group label: Donor fecal microbiota transplant
  other name: FMT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Cyriel Ponsioen, prof.
  phone: +31 20 5668278
  email: c.y.ponsioen@amsterdamumc.nl
  last name: Melanie Benard, Msc
  phone: 0031645050314
  email: m.v.benard@amsterdamumc.nl
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: Cyriel Y Ponsioen
  investigator title: prof. dr.
  mesh term: Colitis
  mesh term: Colitis, Ulcerative
  mesh term: Ulcer
  sharing ipd: Yes
  ipd info type: Study Protocol