[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Alimentiv Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":135},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,62,91,116],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100620855","a-prospective-randomised-study-of-treatment-selection-based-on-epigenetic-markers-versus-standard-of-care-treatment-selection-in-adults-with-crohns-disease-100620855",false,"NCT07363044","A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's Disease","OMICROHN","Inclusion Criteria:\n\nParticipants must meet all of the following criteria for enrolment into the study:\n\n1. Aged 18 years or older at the time of informed consent.\n2. Documented diagnosis of ileal, ileocolonic, or colonic CD (may be confirmed at baseline study endoscopy).\n3. Active CD, as defined by HBI \\> 6 and SES-CD ≥ 6 for colitis\u002Fileocolitis and ≥ 4 for ileitis only.\n4. Eligible to receive either VDZ and\u002For UST therapy for the treatment of CD per the approved drug label requirements and in the opinion of the treating physician.\n5. Must meet all eligibility criteria for biologic therapy initiation as per local SOC, including absence of chronic\u002Fopportunistic infections as demonstrated by local protocols for human immunodeficiency virus, tuberculosis, active cytomegalovirus, hepatitis B and C, and Clostridioides difficile infection. Local vaccination protocols apply as per SOC.\n6. Nonpregnant and nonlactating. Participants of childbearing potential must agree to follow local SOC guidelines for use of biologics in pregnancy\u002Flactation, including appropriate contraception, during the study; must agree to avoid becoming pregnant from the time of informed consent up until Week 26.\n7. If receiving nonbiologic therapies for inflammatory bowel disease, including thiopurines and methotrexate, must have initiated at least 3 months prior to screening and must be on a stable dose for at least 2 weeks prior to screening.\n8. If receiving oral corticosteroids, the participant is eligible if they meet all the following criteria:\n\n   * The dose is up to a maximum of prednisone ≤ 40 mg\u002Fday or budesonide ≤ 9 mg\u002Fday or equivalent.\n   * The dose has been stable for ≥ 2 weeks prior to screening.\n   * The participant is willing to initiate a corticosteroid taper within 2 weeks after initiating biologic treatment.\n9. In the opinion of the investigator, the participant is able to understand and comply with protocol requirements including treatment as assigned per the protocol.\n10. Able to participate fully in all aspects of this clinical study. Full comprehension of consent language and informed consent must be obtained from the participant, or the participant's legally acceptable representative, and documented\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria are to be excluded from the study:\n\n1. Prior treatment with VDZ or UST.\n2. Prior treatment with more than 1 advanced therapy (eg, any biologic \\[ie, anti- tumour necrosis factor (TNF), anti-interleukin, anti-integrin\\]) or advanced oral small molecule \\[ie, Janus kinase inhibitor\\]) for CD.\n3. CD-related complications that in the opinion of the investigator would interfere with participation in the study, including but not limited to:\n\n   * Ileorectal anastomosis (rectum \\\u003C 15 cm), or a proctocolectomy.\n   * Short bowel syndrome.\n   * All ostomies.\n   * Symptomatic strictures in the bowel or symptomatic strictures in the ileum or ileocecal valve that have a stenosis.\n   * Suspected or diagnosed active intra-abdominal or perianal abscess that have not been appropriately treated.\n4. History or current diagnosis of ulcerative colitis (unless this diagnosis was made erroneously), indeterminate colitis, idiopathic colitis (ie, colitis not consistent with CD), microscopic colitis, or colonic mucosal dysplasia (excluding dysplasia in resected adenomas).\n5. Increased risk of infectious complications (eg, recent pyogenic infection, any congenital or acquired immunodeficiency, or past organ, bone marrow, or stem cell transplantation).\n6. Any topical rectal therapy for treatment of CD within 2 weeks prior to the screening endoscopy.\n7. Nonsteroidal anti-inflammatory drugs (NSAIDs) as chronic treatment, except for cyclooxygenase-2logic selective NSAIDS (celecoxib).\n8. Faecal microbiota transplant (includes human microbiota-based therapeutics) within 4 weeks prior to randomisation.\n9. Any major surgery (in the investigator's opinion) performed within 8 weeks prior to randomisation or planned during the study.\n10. History of excessive alcohol or drug abuse that, in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures.\n11. Serious underlying disease other than CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study or would compromise participant safety (such as history of malignancies, major neurological disorders, any unstable or uncontrolled medical disorder, or any known or suspected contraindication to any of the study biologics according to local prescribing information).","ALL","18 Years",{"count":19,"type":20},378,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a multicentre, prospective, randomised, controlled, open-label study to assess the efficacy, safety, and cost-effectiveness of epigenome-guided treatment selection compared to usual standard-of-care (SOC) treatment selection in patients initiating biologic therapy for the treatment of their active Crohn's Disease (CD).",[26],"Crohn Disease (CD)","RECRUITING","2026-05-28",{"date":30,"type":31},"2026-06-01","ACTUAL",{"date":33,"type":31},"2025-02-01",{"date":35,"type":20},"2029-01",{"name":37,"class":38},"Alimentiv Inc.","OTHER",39,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100592786","phase-4-open-label-single-arm-study-to-assess-the-efficacy-of-mirikizumab-in-patients-with-inflammatory-strictures-due-to-cd-100592786","NCT06997965","Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD","An Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to Crohn's Disease","MIRIAD","Inclusion Criteria:\n\n1. Nonpregnant, nonlactating adults, ≥ 18 years of age.\n2. Diagnosis of ileal or ileocolonic CD based on standard clinical, endoscopic, and histologic evidence; established at least 3 months prior to screening.\n3. Presence of at least 1 inflammatory stricture in the terminal ileum\\* within reach of an endoscope (passable or nonpassable). Strictures should be noncritical, naïve or anastomotic stricture(s), caused by CD and confirmed centrally by MRE according to the following criteria:\n\n   * Localized luminal narrowing (luminal diameter ≤ 50% relative to normal adjacent bowel); AND\n   * Bowel wall thickening (≥ 25% relative to adjacent bowel; AND\n   * Either prestenotic dilation (defined as a luminal diameter ≥ 3 cm) or nonpassable with adult colonoscope \\*Note: The terminal ileum is defined as the last 15 cm of ileum proximal to the ileocecal valve or ileocolonic anastomosis. Other small bowel strictures will be considered on a case-by-case basis following discussion with the sponsor. Two strictures within 3 cm are considered the same stricture, and a long segment with multiple areas of narrowing or multiple strictures, that have inflammation between them, is counted as 1 stricture.\n4. Abdominal pain after eating and\u002For limitations in the amount\u002Ftypes of food eaten.\n5. Presence of tolerable obstructive symptoms and not expected to require hospitalization, endoscopic balloon dilation, surgical resection, or additional therapy during the study period. Participants should have sufficient food intake, even with diet modification, defined as a stable weight over 4 weeks prior to initiation of study intervention.\n6. Participants taking oral corticosteroids (eg, ≤ 20 mg\u002Fday prednisone or ≤ 9 mg\u002Fday budesonide) for ≥ 4 weeks prior to screening. Participants must be willing to undergo corticosteroid taper 8 weeks after initiation of study intervention as per standard of care.\n7. Participants can be on stable background therapy for CD and must agree to maintain the background therapy during the study. Acceptable stable background therapies include:\n\n   * Oral 5-ASA drugs or sulfasalazine ≤ 4.8 g per day, for ≥ 4 weeks prior to screening\n   * AZA, 6-MP, or MTX for ≥ 4 weeks prior to Screening\n   * Any rectal therapy for treatment of CD for ≥ 4 weeks prior to screening\n   * Antidiarrheal drugs for ≥ 8 weeks prior to screening\n   * Bile acid sequestrants for ≥ 4 weeks prior to screening\n8. Contraceptive use by study participants should be in accordance with the mirikizumab product monograph and local guidelines.\n9. Signed informed consent.\n\nExclusion Criteria:\n\n1. History or current diagnosis of UC, indeterminate colitis, ischemic colitis, nonsteroidal anti inflammatory drug-induced colitis, idiopathic colitis (ie, colitis not consistent with CD), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.\n2. CD-related complications:\n\n   * Previous extensive small bowel resection, ileorectal anastomosis, or a proctocolectomy, with no more than 2 segments missing.\n   * Short bowel syndrome.\n   * Ileostomy (diverting or end), colostomy, small bowel stoma, or ileoanal pouch.\n   * Inactive fistulae in or adjacent to an ileal stricture. Participants with perianal fistulae could be included provided there is no evidence of peri-anal abscess \\> 2 cm.\n   * Suspected or diagnosed active intra-abdominal or perianal abscess that has not been appropriately treated.\n   * Abscess located \\\u003C 2 cm in relation to the stricture.\n   * Toxic megacolon.\n3. Any major surgery, in the investigator's opinion, performed within 8 weeks prior to screening or planned during the study (ie, any surgical procedure requiring general anesthesia).\n4. Malignancies or history of malignancy within 5 years of the initial screening visit, except for adequately treated or completely excised nonmetastatic basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.\n5. Diagnosis of decompensated liver disease, including but not limited to autoimmune liver disease, viral hepatitis, Wilson disease, or suspected drug-induced liver injury.\n6. Liver chemistry parameters that exceed the following thresholds:\n\n   * ALT or AST \\> 2 × ULN\n   * Alkaline phosphatase \\> 2.5 × ULN\n   * Total bilirubin \\> 1.5 × ULN\n7. Concomitant use of the following medications during the screening period or throughout the study:\n\n   * Cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks prior to screening.\n   * Biologics (anti-tumor necrosis factor, anti-integrins, ustekinumab, or risankizumab) within 8 weeks prior to screening.\n   * JAK inhibitor within 4 weeks prior to screening and throughout the study.\n   * IL23p19 inhibitor within 4 weeks (or 5 half-lives, whichever is longer) prior to screening, or a history of nonresponse or intolerance to IL23p19 inhibitors.\n8. Not up-to-date with current age-appropriate vaccinations in accordance with current immunization guidelines and the investigator's usual standard of care at screening.\n9. Concurrent or previous participation in another clinical trial and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to screening.\n10. Any previous treatment with an antifibrotic therapy, including investigational antifibrotic therapies.\n11. Systemic or opportunistic infections including:\n\n    * HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to Day 0, retesting is not required.\n    * Known active or latent TB; if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before Day 0.\n    * Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin).\n    * Active CMV infection, as per investigator judgement\n    * Other systemic or opportunistic infection, any other clinically significant extraintestinal infection, infection that is not responding to standard treatment, or recurring infection within 6 months of Day 1.\n12. Known or suspected allergy, anaphylaxis, hypersensitivity or intolerance to mirikizumab or its' excipients.\n13. Contraindication to MRE examination or suspected allergy to MRE contrast agent or antispasmodic.\n14. Prior enrolment in the current study and had received study treatment.\n15. Any acute or chronic medical condition, psychiatric disorder, or laboratory abnormality that may increase the risk associated with study participation or study intervention administration, or may interfere with the interpretation of study results, as determined by the investigator.\n16. Unwillingness to withhold protocol-prohibited medications during the trial.",{"count":49,"type":20},60,[51],"PHASE4","This is an open-label, single-arm, phase 4 study to assess the safety and efficacy of mirikizumab in approximately 60 participants with stricturing CD.",[54],"Crohn Disease",{"date":30,"type":31},{"date":57,"type":31},"2026-04-20",{"date":59,"type":20},"2028-04-01",{"name":37,"class":38},2,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100535263","voice-early-response-to-vedolizumab-and-il-23-antagonists-in-participants-with-crohns-disease-a-prospective-observational-study-100535263","NCT06249555","VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study","VOICE-Characterization of Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease Using Patient-Reported Outcome Measures: A Prospective Observational Study","VOICE","Inclusion Criteria:\n\n1. Participant is an adult 18 years of age or older with confirmed CD, as per standard clinical criteria which may include symptoms, endoscopy, histopathology, and imaging.\n2. Participant has active CD and has been prescribed as standard of care (SOC) and is planned to start VDZ or IL-23 antagonist therapy (UST, RISA, or GUS or MIR \\[if approved for the treatment of CD during the recruitment period for this study\\]) for the first time in accordance with the product label, as determined by the treating physician.\n3. Participant has a baseline PROMIS Pain Interference-SF score ≥ 15 (corresponding T-score ≥ 55) (PROMIS Pain Interference-SF 8a \\[V1.1\\]).\n\n   a. Score is calculated by adding score (1 to 5) for each of the 8 subcomponents.\n4. Participant has completed all SOC biologic work-up assessments (this may include assessment of tuberculosis, chronic infections, Clostridioides difficile infection and vaccination status per local practice).\n5. Ability of participant to participate fully in all aspects of this observational study. Full comprehension of consent language and informed consent must be obtained from the participant and documented.\n\nExclusion Criteria:\n\n1. Participant has CD-related surgery planned or anticipated during the study.\n2. Participant has prior exposure to an advanced therapy for the treatment of CD (biologic or small molecule) other than an anti-TNF (i.e., anti-integrin, anti-IL, Janus kinase inhibitors, or sphingosine-1-phosphate receptor 1). Prior failure or intolerance to 2 or more anti-TNF (i.e., infliximab, adalimumab, or certolizumab pegol) therapies in the past 3 years is also cause for exclusion.\n3. Participant has an active infection at baseline requiring intravenous systemic antibiotics.\n\n   Note: The treating physician must have completed all appropriate baseline screening tests as per the product label.\n4. Participant has evidence of C. difficile toxin or is prescribed treatment for C. difficile infection, or other intestinal bacterial pathogen, ≤ 2 weeks prior to Screening.\n5. Participant has chronic non-inflammatory bowel disease pain.",{"count":71,"type":20},300,"OBSERVATIONAL","The primary aim of this study is to explore the time course of response to Vedolizumab in participants with CD as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-short form (SF), as well as other PROMIS domain SFs (fatigue, anxiety, depression, sleep disturbance, physical function, and ability to participate in social roles and activities); other PRO measures will also be assessed.",[75],"Crohn's Disease",[77,78,79,80,81],"Vedolizumab","Ustekinumab","Patient reported outcome","IL-23 antagonists","Risankizumab","2026-02-11",{"date":84,"type":31},"2026-02-13",{"date":86,"type":31},"2024-03-20",{"date":88,"type":20},"2026-12",{"name":37,"class":38},25,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100535890","phase-4-vectors---a-study-to-evaluate-transmural-healing-as-a-treatment-target-in-crohns-disease-100535890","NCT06257706","VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease","An Interventional Study to Evaluate Treating to a Target of Transmural Healing in Patients With Moderately to Severely Active Crohn's Disease","VECTORS","Inclusion Criteria:\n\n1. Adults aged 18 to 80 years, inclusive, at the time of consent;\n2. Moderately to severely active CD at baseline defined by a CDAI score of 220 to 450 inclusive and SES-CD, excluding the presence of narrowing component, ≥6 (or ≥4 for participants with isolated ileal disease);\n3. BWT on IUS of \\>4.0 mm in the terminal ileum or any colonic segment (excluding the rectum) as assessed by the mean of 2 longitudinal and 2 cross-sectional measurements of the same segment;\n4. Biologic-naïve or have previous exposure (within the last 5 years of the screening date) to no more than 1 advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD. Note: only approximately 15% to 30% of the enrolled population will have had prior exposure to an advanced therapeutic;\n5. Participants may continue stable dose (initiated at least 4 weeks prior to Screening) of 5-ASA for CD;\n6. Persons of childbearing potential must have a negative serum pregnancy test prior to randomization and must use a highly effective method of contraception throughout the study. Females unable to bear children must have documentation of such in the source records;\n7. Able to participate fully in all aspects of this clinical trial;\n8. Written informed consent must be obtained and documented.\n\nExclusion Criteria:\n\n1. Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;\n2. Previously exposed to 2 or more compounds or classes of an advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD;\n3. Change to oral corticosteroid therapy dosing within 2 weeks prior to randomization or a corticosteroid dose of \\>40 mg of prednisone or equivalent at randomization;\n4. Only have inflammation proximal to the terminal ileum that cannot be reached by ileocolonoscopy;\n5. Have a CD complication, such as symptomatic strictures in the small bowel with \\>3 cm prestenotic dilatation on any imaging modality, requiring procedural intervention;\n6. Previous extensive colonic resection or missing \\>2 segments out of 5 (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum), ileorectal anastomosis, or a proctocolectomy;\n7. Ostomy or ileoanal pouch;\n8. Short bowel syndrome;\n9. Fibrotic-only stricture in the ileum or colon without evidence of active inflammation (in the investigator's judgment), including any impassable stenosis;\n10. Abscess \\>2 cm, detected by IUS or endoscopy; participants with draining fistulas are not excluded;\n11. Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participant's ability to participate fully in the study or would compromise participant safety;\n12. Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin);\n13. Known HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to randomization, retesting is not required;\n14. Known active or latent tuberculosis (TB); if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before randomization;\n15. Other systemic or opportunistic infection (including cytomegalovirus), any other clinically significant extraintestinal infection, or recurring infection within 6 months of randomization;\n16. Has active cerebral\u002Fmeningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization;\n17. Hypersensitivity, allergy, or intolerance to any excipient of vedolizumab or any other contraindication to vedolizumab;\n18. Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.\n19. Unwillingness to withhold protocol-prohibited medications during the trial;\n20. Concurrent or previous participation in another clinical trial and received any investigational therapy within 30 days prior to randomization;\n21. History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures;\n22. Prior enrolment in the current study and had received study treatment;\n23. Pregnant, lactating, or intending to become pregnant\u002Fimpregnate a partner before, during, or within 18 weeks after the last dose; or intending to donate ova or sperm during such time period;\n24. Vaccination with a live or live-attenuated vaccine within 4 weeks prior to randomization, or planned vaccination with a live or live-attenuated vaccine during participation in the study;\n25. Any person performing mandatory military service, deprived of liberty, in a residential care setting, or any person who, due to a judicial decision, cannot take part in clinical studies;\n26. The person is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling).","80 Years",{"count":101,"type":20},304,[51],"Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target. Observational studies suggest that TMH may be associated with better long-term outcomes. The study will evaluate TMH using noninvasive intestinal ultrasound (IUS), a patient-friendly technique that can be performed routinely in clinical practice. The aim of the study is to determine if treating to a target of corticosteroid-free (CS-free) IUS outcomes + clinical symptoms + biomarkers is superior to a target of clinical symptoms + biomarkers alone in achieving CS-free endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD).\n\nQualified participants will be randomly assigned in a 1:1 ratio to one of 2 different target treatment groups.\n\nGroup 1: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission. At Week 22 and 30, the IUS-based component of the target will be IUS response and at Week 38, the final treatment target will be TMH. Group 2: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.",[105,54,106],"Moderately to Severely Active Crohn's Disease","Disease Crohn","2026-01-14",{"date":109,"type":31},"2026-01-15",{"date":111,"type":31},"2024-08-07",{"date":113,"type":20},"2029-02-06",{"name":37,"class":38},69,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":5},"100567626","development-of-a-novel-endoscopic-index-and-patient-reported-outcome-measure-for-clinical-trials-in-participants-with-permanent-ileostomy-100567626","NCT06670638","Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy","Inclusion Criteria:\n\n1. Adults (age ≥ 18 years) with a diagnosis of CD treated surgically with subtotal colectomy\u002Fproctocolectomy end ileostomy at least 12 months prior to the scheduled endoscopy procedure.\n2. Planning to have an ileoscopy procedure scheduled as part of routine medical care.\n3. Be proficient in the English language (ie, ability to read, write, speak, and understand English well enough to take part in the interview process without the aid of an interpreter).\n4. Able and willing to participate fully in all aspects of this study.\n5. Written informed consent must be obtained and documented.\n\nExclusion Criteria:\n\n1. End or loop colostomy, end ileostomy for UC, continent ileostomy, ileal pouch anal anastomosis, end ileostomy with mucous fistula, double barrel ileostomy, urostomy, loop ostomy, or any type of end ileostomy not considered permanent at the time of enrolment (with no intent to restore continuity).\n2. Peristomal skin complications such as pyoderma gangrenosum, abscess, or any other severe peristomal skin inflammation.\n3. Stomal stenosis obviating ileoscopy, known small bowel stricture, major stoma prolapse, symptomatic parastomal hernia, parastomal hernia with subcutaneous loops of small bowel within the hernia, stoma in a crease\u002Fpoorly fitting applicable resulting in severe peristomal skin irritation, or retracted stoma that prevents endoscopic evaluation.\n4. Any actively draining fistula (eg, peristomal or peri-anal).\n5. Evidence of a known small bowel stricture on cross-sectional imaging or inability to pass an endoscope within the past 6 months.\n6. Known active Clostridoides difficile or other enteric infection.\n7. Short bowel syndrome.\n8. Predominant symptom(s) arising from a retained rectal stump.\n9. Serious underlying disease other than CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study procedures or provide nonconfounded descriptions of their CD and ostomy symptom experiences during the interview.\n10. Prior enrolment in the current study.",{"count":123,"type":20},50,"To date, patients with Crohn's Disease (CD) and permanent ileostomies have been excluded from clinical trials for new treatments. To allow this patient population to be included in clinical trials, outcome and measurement tools are needed. This study aims to develop a Patient Reported Outcome (PRO) and Endoscopic Index (EI) for patients with Crohn's Disease (CD) and permanent ileostomy. The study will enroll about 50 participants and collect videos of endoscopies that are done as part of standard of care. The videos will be centrally read to identify features that represent a broad range of inflammation and will be used to develop the EI. Participants will also be asked to participate in interviews, to understand the symptoms and impacts that are most important to participants for the development of a PRO.",[126],"Crohns Disease","2025-11-07",{"date":129,"type":31},"2025-11-12",{"date":131,"type":31},"2024-06-19",{"date":133,"type":20},"2027-02-28",{"name":37,"class":38},""]