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/NCT05987852</url>
    </required_header>
    <id_info>
      <org_study_id>HBOT-UC</org_study_id>
      <secondary_id>1U01DK134321</secondary_id>
      <nct_id>NCT05987852</nct_id>
    </id_info>
    <brief_title>Hyperbaric Oxygen Therapy for Ulcerative Colitis</brief_title>
    <acronym>HBOT-UC</acronym>
    <official_title>Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Northwestern University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Northwestern University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative&#xD;
        colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased&#xD;
        atmospheric pressure to increase tissue oxygenation. Two small prospective randomized&#xD;
        controlled trials have demonstrated that the delivery of HBOT to UC patients hospitalized for&#xD;
        acute moderate to severe flares results in improved remission rates and avoidance of&#xD;
        in-hospital progression to biologics, small molecules, or colectomy. In this larger trial the&#xD;
        study aims to confirm the treatment benefits of HBOT for hospitalized UC patients and study&#xD;
        the immune-microbe mechanisms underpinning treatment response.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2027</primary_completion_date>
    <phase>N/A</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>
      <intervention_model_description>5-day intervention period; 12 months observational period through standard of care visits and follow-up</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical response defined as complete resolution of rectal bleeding and improvement in stool frequency, without need for in-hospital biologics, small molecules, or colectomy by study day 5</measure>
      <time_frame>Day 5</time_frame>
      <description>Proportion of participants achieving clinical response as measured by complete resolution of rectal bleeding (Mayo rectal bleeding sub-score of 0) and improvement in stool frequency (at least 1 point reduction in Mayo stool frequency sub-score), without the need for in-hospital biologics, small molecules, or colectomy, by study day 5.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Endoscopic Improvement</measure>
      <time_frame>Day 5; Day 90</time_frame>
      <description>Proportion of participants achieving endoscopic improvement (Mayo endoscopic sub-score of 0 or 1)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Endoscopic Remission</measure>
      <time_frame>Day 5; Day 90</time_frame>
      <description>Proportion of participants achieving Endoscopic remission (Mayo endoscopic sub-score of 0)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Histologic Remission</measure>
      <time_frame>Day 5; Day 90</time_frame>
      <description>Proportion of participants achieving Histologic Remission (Geboes histology score ≤ 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mucosal Healing</measure>
      <time_frame>Day 5; Day 90</time_frame>
      <description>Proportion of participants achieving Mucosal Healing (Endoscopic sub-score 0 or 1 + Geboes histology score ≤ 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Remission</measure>
      <time_frame>Day 3; Day 5; 12 months</time_frame>
      <description>Proportion of participants achieving clinical remission (Full Mayo ≤ 2, with no sub-score &gt; 1)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Initiation and/or adjustment of biologics or small molecule inhibitors</measure>
      <time_frame>12 months</time_frame>
      <description>Proportion of participants who require initiation and/or adjustment in biologics or small molecule inhibitors, and number of biologics or small molecule inhibitors and/or adjustments required over 12 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Colectomy</measure>
      <time_frame>Day 5; 12 months</time_frame>
      <description>Proportion of participants requiring colectomy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Re-hospitalization</measure>
      <time_frame>12 months</time_frame>
      <description>Proportion of participants with any re-hospitalization during the follow-up period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serious Infections or Serious Adverse Events</measure>
      <time_frame>Day 5</time_frame>
      <description>Proportion of participants experiencing any serious infections or serious adverse events during intervention period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of new initiations and/or adjustments in biologics or small molecule inhibitors</measure>
      <time_frame>12 months</time_frame>
      <description>Number of new initiations and/or adjustments in biologics or small molecule inhibitors</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of index hospitalization</measure>
      <time_frame>From date of hospitalization to time of discharge, assessed up to 30 days</time_frame>
      <description>Duration of index hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of re-hospitalizations</measure>
      <time_frame>12 months</time_frame>
      <description>Number of re-hospitalizations</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in inflammation, as measured by C-reactive protein</measure>
      <time_frame>Day 3; Day 5</time_frame>
      <description>Change in inflammation, as measured by C-reactive protein</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in inflammation, as measured by fecal calprotectin</measure>
      <time_frame>Day 5</time_frame>
      <description>Change in inflammation, as measured by fecal calprotectin</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Full Mayo Score</measure>
      <time_frame>Day 5; Day 90</time_frame>
      <description>Score ranges from 0-12 ; higher scores are worse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ulcerative Colitis Endoscopic Index of Severity (UCEIS)</measure>
      <time_frame>Day 5; Day 90</time_frame>
      <description>Score ranges from 0-8 ; higher scores are worse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Numeric Urgency Rating Score</measure>
      <time_frame>Day 3; Day 5</time_frame>
      <description>Score ranges from 0-10 ; higher scores are worse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement in individual Mayo sub-score for stool frequency</measure>
      <time_frame>Day 3; Day 5</time_frame>
      <description>Score ranges from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement in individual Mayo sub-score for rectal bleeding</measure>
      <time_frame>Day 3; Day 5</time_frame>
      <description>Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement in individual Mayo Endoscopic sub-score for mucosal appearance at endoscopy</measure>
      <time_frame>Day 5</time_frame>
      <description>Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement in individual Mayo sub-score for physician rating of disease activity</measure>
      <time_frame>Day 3; Day 5</time_frame>
      <description>Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement in urgency Simple Clinical Colitis Activity Index (SCCAI) sub-score</measure>
      <time_frame>Day 3; Day 5</time_frame>
      <description>Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement in nocturnal bowel movement frequency Simple Clinical Colitis Activity Index (SCCAI) sub-score</measure>
      <time_frame>Day 3; Day 5</time_frame>
      <description>Scores range from 0-2 ; higher scores are worse ; improvement defined as decrease in score from baseline</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">126</enrollment>
    <condition>Ulcerative Colitis</condition>
    <arm_group>
      <arm_group_label>Hyperbaric Oxygen Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants enrolled in the active intervention group receiving HBOT will undergo compression to 2.4 Atmospheres Absolute (ATA; 100% O2) for 90 minutes with two 5-10 minute &quot;air breaks&quot; (breathing room air at the 2.4 ATA) during the session. This is done once a day for 5 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham Hyperbaric Air</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>This control arm will undergo compression to 1.34 ATA for monoplace chambers and 2.4 ATA for multiplace chambers for the full 90-minute session but 21% oxygen instead of 100% oxygen being administered. These participants will also have two 5-10 minute &quot;air breaks&quot; to mimic the treatment protocol. Multiplace sham sessions will have modified air breaks to avoid decompression sickness. This will happen once a day for 5 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Hyperbaric Oxygen Therapy</intervention_name>
      <description>Participants enrolled in the active intervention group receiving HBOT will undergo compression to 2.4 Atmospheres Absolute (ATA; 100% O2) for 90 minutes with two 5-10 minute &quot;air breaks&quot; (breathing room air at the 2.4 ATA) during the session. This is done once a day for 5 days.</description>
      <arm_group_label>Hyperbaric Oxygen Therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sham Hyperbaric Air</intervention_name>
      <description>This control arm will undergo compression to 1.34 ATA for monoplace chambers and 2.4 ATA for multiplace chambers for the full 90-minute session but 21% oxygen instead of 100% oxygen being administered. These participants will also have two 5-10 minute &quot;air breaks&quot; to mimic the treatment protocol. Multiplace sham sessions will have modified air breaks to avoid decompression sickness. This will happen once a day for 5 days.</description>
      <arm_group_label>Sham Hyperbaric Air</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants with known or newly diagnosed UC who require hospitalization for an acute&#xD;
               moderate to severe flare&#xD;
  &#xD;
            -  Age 18-85&#xD;
  &#xD;
            -  Consented and able to receive first HBOT session within first 48 hours of initiation&#xD;
               of intravenous steroids&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Complication requiring urgent surgical intervention&#xD;
  &#xD;
            -  Toxic megacolon&#xD;
  &#xD;
            -  Inability to receive intravenous steroids&#xD;
  &#xD;
            -  Historically failed 3 or more classes of advanced therapeutic options&#xD;
  &#xD;
            -  Known or suspected diagnosis of Crohn's colitis, indeterminate colitis, ischemic&#xD;
               colitis, radiation colitis, diverticular disease associated with colitis, microscopic&#xD;
               colitis or infectious colitis&#xD;
  &#xD;
            -  Received any investigational drug within 30 days&#xD;
  &#xD;
            -  Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic&#xD;
               impairment that increases the risk for HBOT toxicity&#xD;
  &#xD;
            -  Women who are pregnant or nursing&#xD;
  &#xD;
            -  Unwillingness to complete course of HBOT&#xD;
  &#xD;
            -  Active SARS CoV 2 infection&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lauren Balmert Bonner, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Northwestern University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yasmin Pina, BS</last_name>
      <phone>312-503-6459</phone>
      <email>yasmin.pina@northwestern.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mary Beth Tull, MS</last_name>
      <phone>312-503-4746</phone>
      <email>mary.tull@northwestern.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Alabama Medicine</name>
        <address>
          <city>Birmingham</city>
          <state>Alabama</state>
          <zip>35233</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kirk Russ, MD</last_name>
        <email>kruss@uabmc.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Los Angeles Health</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90024</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jenny Sauk, MD</last_name>
        <email>jsauk@mednet.ucla.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Miami Health</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33136</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Oriana Mazorra, MD</last_name>
        <email>omazorra@med.miami.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Orlando Health</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32806</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Udayakumar Navaneethan, MD</last_name>
        <email>udayakumar.navaneethan@orlandohealth.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lake Forest Hospital</name>
        <address>
          <city>Lake Forest</city>
          <state>Illinois</state>
          <zip>60045</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Paramir S Dulai, MD</last_name>
        <email>parambir.dulai@northwestern.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Louisville</name>
        <address>
          <city>Louisville</city>
          <state>Kentucky</state>
          <zip>40202</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Gerald Dryden, MD</last_name>
        <email>tad.dryden@louisville.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Maryland Medical Center</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21201</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Raymond Cross, MD</last_name>
        <email>rcross@som.umaryland.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tufts Medical Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02111</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lilani Perera, MD</last_name>
        <email>perera.lilani@icloud.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Massachusetts General Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ashwin Ananthakrishnan, MD</last_name>
        <email>aananthakrishnan@mgh.harvard.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Mayo Clinic</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Laura Raffals, MD</last_name>
        <email>raffals.laura@mayo.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dartmouth Hitchcock Medical Center</name>
        <address>
          <city>Lebanon</city>
          <state>New Hampshire</state>
          <zip>03756</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Corey Siegel, MD</last_name>
        <email>corey.a.siegel@hitchcock.org</email>
      </contact>
      <contact_backup>
        <last_name>Michael Winter, MD</last_name>
        <email>michael.w.winter@hitchcock.org</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>New York University Langone Health</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10016</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>David Hudesman, MD</last_name>
        <email>david.hudesman@nyulangone.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Cornell University Medical Center</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10065</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Dana Lukin, MD</last_name>
        <email>djl9010@med.cornell.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>State University of New York Upstate Medical University</name>
        <address>
          <city>Syracuse</city>
          <state>New York</state>
          <zip>13210</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Marvin Heyboer, MD</last_name>
        <email>HeyboerM@upstate.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Oregon Health &amp; Science University Health</name>
        <address>
          <city>Portland</city>
          <state>Oregon</state>
          <zip>97239</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Anthony Sofia, MD</last_name>
        <email>sofia@ohsu.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Allegheny Health</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15090</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Gursimran Kochhar, MD</last_name>
        <email>gursimran.kochhar@ahn.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Pittsburgh Medical Center</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15213</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jeffrey Dueker, MD</last_name>
        <email>duekerjm@upmc.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Medical University of South Carolina</name>
        <address>
          <city>Charleston</city>
          <state>South Carolina</state>
          <zip>29425</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Erin Forster, MD</last_name>
        <email>forstere@musc.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Virginia Health</name>
        <address>
          <city>Charlottesville</city>
          <state>Virginia</state>
          <zip>22903</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Anne Tuskey, MD</last_name>
        <email>agt2w@hscmail.mcc.virginia.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Northwestern University</investigator_affiliation>
      <investigator_full_name>Lauren C Balmert</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>hyperbaric oxygen therapy</keyword>
    <keyword>HBOT</keyword>
    <keyword>ulcerative colitis</keyword>
    <keyword>hyperbaric oxygen</keyword>
    <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_description>Dataset with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</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/NCT05987852
  org study id: HBOT-UC
  secondary id: 1U01DK134321
  nct id: NCT05987852
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative
        colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased
        atmospheric pressure to increase tissue oxygenation. Two small prospective randomized
        controlled trials have demonstrated that the delivery of HBOT to UC patients hospitalized for
        acute moderate to severe flares results in improved remission rates and avoidance of
        in-hospital progression to biologics, small molecules, or colectomy. In this larger trial the
        study aims to confirm the treatment benefits of HBOT for hospitalized UC patients and study
        the immune-microbe mechanisms underpinning treatment response.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 5-day intervention period; 12 months observational period through standard of care visits and follow-up
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Clinical response defined as complete resolution of rectal bleeding and improvement in stool frequency, without need for in-hospital biologics, small molecules, or colectomy by study day 5
  time frame: Day 5
  description: Proportion of participants achieving clinical response as measured by complete resolution of rectal bleeding (Mayo rectal bleeding sub-score of 0) and improvement in stool frequency (at least 1 point reduction in Mayo stool frequency sub-score), without the need for in-hospital biologics, small molecules, or colectomy, by study day 5.
  measure: Endoscopic Improvement
  time frame: Day 5; Day 90
  description: Proportion of participants achieving endoscopic improvement (Mayo endoscopic sub-score of 0 or 1)
  measure: Endoscopic Remission
  time frame: Day 5; Day 90
  description: Proportion of participants achieving Endoscopic remission (Mayo endoscopic sub-score of 0)
  measure: Histologic Remission
  time frame: Day 5; Day 90
  description: Proportion of participants achieving Histologic Remission (Geboes histology score ≤ 2)
  measure: Mucosal Healing
  time frame: Day 5; Day 90
  description: Proportion of participants achieving Mucosal Healing (Endoscopic sub-score 0 or 1 + Geboes histology score ≤ 2)
  measure: Clinical Remission
  time frame: Day 3; Day 5; 12 months
  description: Proportion of participants achieving clinical remission (Full Mayo ≤ 2, with no sub-score > 1)
  measure: Initiation and/or adjustment of biologics or small molecule inhibitors
  time frame: 12 months
  description: Proportion of participants who require initiation and/or adjustment in biologics or small molecule inhibitors, and number of biologics or small molecule inhibitors and/or adjustments required over 12 months
  measure: Colectomy
  time frame: Day 5; 12 months
  description: Proportion of participants requiring colectomy
  measure: Re-hospitalization
  time frame: 12 months
  description: Proportion of participants with any re-hospitalization during the follow-up period
  measure: Serious Infections or Serious Adverse Events
  time frame: Day 5
  description: Proportion of participants experiencing any serious infections or serious adverse events during intervention period
  measure: Number of new initiations and/or adjustments in biologics or small molecule inhibitors
  time frame: 12 months
  description: Number of new initiations and/or adjustments in biologics or small molecule inhibitors
  measure: Duration of index hospitalization
  time frame: From date of hospitalization to time of discharge, assessed up to 30 days
  description: Duration of index hospitalization
  measure: Number of re-hospitalizations
  time frame: 12 months
  description: Number of re-hospitalizations
  measure: Change in inflammation, as measured by C-reactive protein
  time frame: Day 3; Day 5
  description: Change in inflammation, as measured by C-reactive protein
  measure: Change in inflammation, as measured by fecal calprotectin
  time frame: Day 5
  description: Change in inflammation, as measured by fecal calprotectin
  measure: Full Mayo Score
  time frame: Day 5; Day 90
  description: Score ranges from 0-12 ; higher scores are worse
  measure: Ulcerative Colitis Endoscopic Index of Severity (UCEIS)
  time frame: Day 5; Day 90
  description: Score ranges from 0-8 ; higher scores are worse
  measure: Numeric Urgency Rating Score
  time frame: Day 3; Day 5
  description: Score ranges from 0-10 ; higher scores are worse
  measure: Improvement in individual Mayo sub-score for stool frequency
  time frame: Day 3; Day 5
  description: Score ranges from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
  measure: Improvement in individual Mayo sub-score for rectal bleeding
  time frame: Day 3; Day 5
  description: Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
  measure: Improvement in individual Mayo Endoscopic sub-score for mucosal appearance at endoscopy
  time frame: Day 5
  description: Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
  measure: Improvement in individual Mayo sub-score for physician rating of disease activity
  time frame: Day 3; Day 5
  description: Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
  measure: Improvement in urgency Simple Clinical Colitis Activity Index (SCCAI) sub-score
  time frame: Day 3; Day 5
  description: Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
  measure: Improvement in nocturnal bowel movement frequency Simple Clinical Colitis Activity Index (SCCAI) sub-score
  time frame: Day 3; Day 5
  description: Scores range from 0-2 ; higher scores are worse ; improvement defined as decrease in score from baseline
  arm group label: Hyperbaric Oxygen Therapy
  arm group type: Experimental
  description: Participants enrolled in the active intervention group receiving HBOT will undergo compression to 2.4 Atmospheres Absolute (ATA; 100% O2) for 90 minutes with two 5-10 minute "air breaks" (breathing room air at the 2.4 ATA) during the session. This is done once a day for 5 days.
  arm group label: Sham Hyperbaric Air
  arm group type: Sham Comparator
  description: This control arm will undergo compression to 1.34 ATA for monoplace chambers and 2.4 ATA for multiplace chambers for the full 90-minute session but 21% oxygen instead of 100% oxygen being administered. These participants will also have two 5-10 minute "air breaks" to mimic the treatment protocol. Multiplace sham sessions will have modified air breaks to avoid decompression sickness. This will happen once a day for 5 days.
  intervention type: Device
  intervention name: Hyperbaric Oxygen Therapy
  description: Participants enrolled in the active intervention group receiving HBOT will undergo compression to 2.4 Atmospheres Absolute (ATA; 100% O2) for 90 minutes with two 5-10 minute "air breaks" (breathing room air at the 2.4 ATA) during the session. This is done once a day for 5 days.
  arm group label: Hyperbaric Oxygen Therapy
  intervention type: Other
  intervention name: Sham Hyperbaric Air
  description: This control arm will undergo compression to 1.34 ATA for monoplace chambers and 2.4 ATA for multiplace chambers for the full 90-minute session but 21% oxygen instead of 100% oxygen being administered. These participants will also have two 5-10 minute "air breaks" to mimic the treatment protocol. Multiplace sham sessions will have modified air breaks to avoid decompression sickness. This will happen once a day for 5 days.
  arm group label: Sham Hyperbaric Air
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Lauren Balmert Bonner, PhD
  role: Principal Investigator
  affiliation: Northwestern University
  last name: Yasmin Pina, BS
  phone: 312-503-6459
  email: yasmin.pina@northwestern.edu
  last name: Mary Beth Tull, MS
  phone: 312-503-4746
  email: mary.tull@northwestern.edu
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  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Northwestern University
  investigator full name: Lauren C Balmert
  investigator title: Associate Professor
  mesh term: Colitis
  mesh term: Colitis, Ulcerative
  mesh term: Ulcer
  sharing ipd: Yes
  ipd description: Dataset with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository.
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)