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/NCT06042582</url>
    </required_header>
    <id_info>
      <org_study_id>Algae4IBD</org_study_id>
      <nct_id>NCT06042582</nct_id>
    </id_info>
    <brief_title>From Nature to Bedside- Algae Based Bio Compound for Prevention and Treatment of Inflammation, Pain and IBD</brief_title>
    <official_title>From Nature to Bedside- Algae Based Bio Compound for Prevention and Treatment of Inflammation, Pain and IBD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>IRCCS San Raffaele</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>IRCCS San Raffaele</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>
        This study is part of the project funded by the Horizon2020 program for establishing the&#xD;
        consortium Algae4IBD (https://algae4ibd.eu/), where OSR participates as a partner. It aims to&#xD;
        promote the implementation of the European Crohn's and Colitis Organization (ECCO/FECCO)&#xD;
        Directive and the benefit of the Inflammatory Bowel Disease (IBD) patient's wellness by&#xD;
        finding innovative algae based novel small molecule therapeutics. A systemic approach to&#xD;
        eco-innovation is adopted to create interconnections between sectors, value chains, natural&#xD;
        resources, and relevant societal stewards. To this end, the consortium has set specific&#xD;
        objectives to achieve holistic innovations, including technical, economic, health, and social&#xD;
        factors that all work in concert.&#xD;
  &#xD;
        IBD included Crohn's disease and ulcerative colitis. It is a class of chronic inflammatory&#xD;
        disorders with complex pathogenesis. Despite the lack of a full understanding of its&#xD;
        etiogenesis, many anti-inflammatory treatments have been developed over the last decades.&#xD;
        However, not all patients may benefit from these treatments and some of them are refractory&#xD;
        to the current therapies or experience relapse of the disease. Therefore, there is still an&#xD;
        urgent need to find an innovative line of interventions for ameliorating these patients'&#xD;
        overall quality of life.&#xD;
  &#xD;
        Algae4IBD consortium will form a bridge between innovation and market demands to prevent and&#xD;
        treat inflammation, pain, and IBD. Bioactive molecule/compounds extracts from microalgae,&#xD;
        cyanobacteria, and macro-algae (MiaCyMa) are an inexhaustible untapped natural source for&#xD;
        products destined for IBD prevention and treatment (inflammation, pain, and the disease&#xD;
        process associated with the gut's microbiome). The natural source potential is still more&#xD;
        promising when considering extremophile strains for excellent metabolism systems. Moreover,&#xD;
        the production of the natural source of biological materials should be sustainable. Indeed,&#xD;
        the non-genetically modified organisms (GMO cultures offer numerous advantages such as&#xD;
        reduced requirements of fresh water and land (no arable land is required), drastic reduction&#xD;
        of nitrogen sources, and potential environmental threats. Algae4IBD concept will include a&#xD;
        multi-step screening approach and feedback loops across the project steps to achieve its&#xD;
        goals. Specifically, OSR is in charge with work package (WP) 4, task 4.4, which aims to&#xD;
        characterize the activity of plant cell (algae) extracts named in this proposal as &quot;natural&#xD;
        compounds&quot; of algae provided by the consortium in ex-vivo models, using bioptic samples&#xD;
        derived from patients with IBD (patients with ulcerative colitis (UC) and Crohn's disease&#xD;
        (CD)), comparing them to samples derived from patients without UC and CD.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2025</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate the response of intestinal mucosa samples to treatments with natural compounds derived from algae in terms of release of pro-inflammatory factors (1), transcriptomics, metatranscriptomics (2) and lipidomics analysis (3)</measure>
      <time_frame>30 months</time_frame>
      <description>Release of pro-inflammatory cytokines using ELISA&#xD;
  RNA-Seq-generated FASTQ reads from human colons will be quality filtered and adaptor trimmed with NCBI fastq-dump.&#xD;
  Lipids detected by LC-MS/MS will be classified based on their precursors, and, in parallel, based on their metabolic pathways.&#xD;
  By multi-omic factor analysis we will integrate these data with the patients' clinical parameters, correlating among each other in parallel and giving one single output (outcome measure, in our case, multiomic factor) explaining how the different omic layers are assigned simultaneously to specific clinical characteristics, thus resulting as associated with, or predictive of, the clinical progression of IBD.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">90</enrollment>
    <condition>IBD</condition>
    <arm_group>
      <arm_group_label>Ulcerative Colitis (UC)</arm_group_label>
      <description>subjects undergoing endoscopy and biopsies collection per standard of care&#xD;
  adult patients ≥18 and &lt;60 years&#xD;
  clinical and endoscopic evaluation (Mayo score≥2)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Crohn's Disease (CD)</arm_group_label>
      <description>subjects undergoing endoscopy and biopsies collection per standard of care&#xD;
  adult patients ≥18 and &lt;60 years&#xD;
  clinical and endoscopic evaluation (Harvey-Bradshaw score ≥5 and overall simplified endoscopic score (SES-CD) &gt;2)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>NO UC/CD</arm_group_label>
      <description>subjects undergoing endoscopy and biopsies collection (≥18 and &lt;60 years) according to the normal clinical practice (as patients undergoing cancer surveillance, irritable bowel syndrome (IBS), diarrhea)&#xD;
  subjects not affected by UC or CD according to the previously reported clinical and endoscopic evaluation criteria</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Additional biopsies collection</intervention_name>
      <description>We will recruit only subjects (UC, CD and NO-UC/CD) scheduled for the endoscopy and biopsies-collection according to the usual clinical practice. During the endoscopy we will collect 6 additional biopsies.</description>
      <arm_group_label>Crohn's Disease (CD)</arm_group_label>
      <arm_group_label>NO UC/CD</arm_group_label>
      <arm_group_label>Ulcerative Colitis (UC)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          We will recruit adult patients with CD or UC and without CD and UC, ≥18 and &lt;60 years and&#xD;
          without any previously documented gastrointestinal infections in collaboration with the&#xD;
          Gastroenterology and Digestive Endoscopy unit (IRCSS Ospedale San Raffaele). CD and UC&#xD;
          diagnosis will be determined by clinical and endoscopic scores (described below in&#xD;
          inclusion criteria). Control data will come from the same intestinal areas of age-matched&#xD;
          no-UC/CD subjects undergoing endoscopic surveillance for not IBD-related conditions&#xD;
          (described into the inclusion criteria) according to the standard of care.&#xD;
  &#xD;
          The participation is voluntary and the patient is allowed to refuse further participation&#xD;
          in the protocol whenever he/she wants.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          INCLUSION CRITERIA&#xD;
  &#xD;
          SUBJECTS WITH THE DIAGNOSIS OF UC OR CD:&#xD;
  &#xD;
            -  subjects undergoing endoscopy and biopsies collection per standard of care&#xD;
  &#xD;
            -  adult patients ≥18 and &lt;60 years&#xD;
  &#xD;
          Additionally, for people with UC:&#xD;
  &#xD;
          - clinical and endoscopic evaluation (Mayo score≥2)&#xD;
  &#xD;
          Additionally, for individuals with CD:&#xD;
  &#xD;
          - clinical and endoscopic evaluation (Harvey-Bradshaw score ≥5 and overall simplified&#xD;
          endoscopic score (SES-CD) &gt;2)&#xD;
  &#xD;
          SUBJECTS NOT AFFECTED BY UC OR CD:&#xD;
  &#xD;
            -  subjects undergoing endoscopy and biopsies collection (≥18 and &lt;60 years) according to&#xD;
               the normal clinical practice (as patients undergoing cancer surveillance, irritable&#xD;
               bowel syndrome (IBS), diarrhea)&#xD;
  &#xD;
            -  subjects not affected by UC or CD according to the previously reported clinical and&#xD;
               endoscopic evaluation criteria All patients will sign the informed consent.&#xD;
  &#xD;
          EXCLUSION CRITERIA&#xD;
  &#xD;
          SUBJECTS WITH THE DIAGNOSIS OF UC OR CD:&#xD;
  &#xD;
          - subjects with UC or CD who do not have the previously described clinical and endoscopic&#xD;
          evaluation criteria&#xD;
  &#xD;
          SUBJECTS NOT AFFECTED BY UC OR CD (CONTROL GROUP):&#xD;
  &#xD;
          -subjects undergoing anti-inflammatory and/or immunosuppressive treatments for other&#xD;
          diseases not related to UC or CD&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>IRCCS San Raffaele</investigator_affiliation>
      <investigator_full_name>Silvio Danese</investigator_full_name>
      <investigator_title>Director of Gastroenterology and Endoscopy Unit</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT06042582
  org study id: Algae4IBD
  nct id: NCT06042582
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is part of the project funded by the Horizon2020 program for establishing the
        consortium Algae4IBD (https://algae4ibd.eu/), where OSR participates as a partner. It aims to
        promote the implementation of the European Crohn's and Colitis Organization (ECCO/FECCO)
        Directive and the benefit of the Inflammatory Bowel Disease (IBD) patient's wellness by
        finding innovative algae based novel small molecule therapeutics. A systemic approach to
        eco-innovation is adopted to create interconnections between sectors, value chains, natural
        resources, and relevant societal stewards. To this end, the consortium has set specific
        objectives to achieve holistic innovations, including technical, economic, health, and social
        factors that all work in concert.
  
        IBD included Crohn's disease and ulcerative colitis. It is a class of chronic inflammatory
        disorders with complex pathogenesis. Despite the lack of a full understanding of its
        etiogenesis, many anti-inflammatory treatments have been developed over the last decades.
        However, not all patients may benefit from these treatments and some of them are refractory
        to the current therapies or experience relapse of the disease. Therefore, there is still an
        urgent need to find an innovative line of interventions for ameliorating these patients'
        overall quality of life.
  
        Algae4IBD consortium will form a bridge between innovation and market demands to prevent and
        treat inflammation, pain, and IBD. Bioactive molecule/compounds extracts from microalgae,
        cyanobacteria, and macro-algae (MiaCyMa) are an inexhaustible untapped natural source for
        products destined for IBD prevention and treatment (inflammation, pain, and the disease
        process associated with the gut's microbiome). The natural source potential is still more
        promising when considering extremophile strains for excellent metabolism systems. Moreover,
        the production of the natural source of biological materials should be sustainable. Indeed,
        the non-genetically modified organisms (GMO cultures offer numerous advantages such as
        reduced requirements of fresh water and land (no arable land is required), drastic reduction
        of nitrogen sources, and potential environmental threats. Algae4IBD concept will include a
        multi-step screening approach and feedback loops across the project steps to achieve its
        goals. Specifically, OSR is in charge with work package (WP) 4, task 4.4, which aims to
        characterize the activity of plant cell (algae) extracts named in this proposal as "natural
        compounds" of algae provided by the consortium in ex-vivo models, using bioptic samples
        derived from patients with IBD (patients with ulcerative colitis (UC) and Crohn's disease
        (CD)), comparing them to samples derived from patients without UC and CD.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: To evaluate the response of intestinal mucosa samples to treatments with natural compounds derived from algae in terms of release of pro-inflammatory factors (1), transcriptomics, metatranscriptomics (2) and lipidomics analysis (3)
  time frame: 30 months
  description: Release of pro-inflammatory cytokines using ELISA
  RNA-Seq-generated FASTQ reads from human colons will be quality filtered and adaptor trimmed with NCBI fastq-dump.
  Lipids detected by LC-MS/MS will be classified based on their precursors, and, in parallel, based on their metabolic pathways.
  By multi-omic factor analysis we will integrate these data with the patients' clinical parameters, correlating among each other in parallel and giving one single output (outcome measure, in our case, multiomic factor) explaining how the different omic layers are assigned simultaneously to specific clinical characteristics, thus resulting as associated with, or predictive of, the clinical progression of IBD.
  arm group label: Ulcerative Colitis (UC)
  description: subjects undergoing endoscopy and biopsies collection per standard of care
  adult patients ≥18 and <60 years
  clinical and endoscopic evaluation (Mayo score≥2)
  arm group label: Crohn's Disease (CD)
  description: subjects undergoing endoscopy and biopsies collection per standard of care
  adult patients ≥18 and <60 years
  clinical and endoscopic evaluation (Harvey-Bradshaw score ≥5 and overall simplified endoscopic score (SES-CD) >2)
  arm group label: NO UC/CD
  description: subjects undergoing endoscopy and biopsies collection (≥18 and <60 years) according to the normal clinical practice (as patients undergoing cancer surveillance, irritable bowel syndrome (IBS), diarrhea)
  subjects not affected by UC or CD according to the previously reported clinical and endoscopic evaluation criteria
  intervention type: Procedure
  intervention name: Additional biopsies collection
  description: We will recruit only subjects (UC, CD and NO-UC/CD) scheduled for the endoscopy and biopsies-collection according to the usual clinical practice. During the endoscopy we will collect 6 additional biopsies.
  arm group label: Crohn's Disease (CD)
  arm group label: NO UC/CD
  arm group label: Ulcerative Colitis (UC)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: IRCCS San Raffaele
  investigator full name: Silvio Danese
  investigator title: Director of Gastroenterology and Endoscopy Unit
  mesh term: Inflammation
  sharing ipd: Undecided