[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527365":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":54,"locations":63,"responsibleParty":85,"collaborators":36,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":36,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":36,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":110,"overallStatus":66,"whyStopped":36,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"High intensity fIR therapy","EXPERIMENTAL","Patients will undergo 10 sessions of 30 minutes high intensity (approximately 70˚C) fIR therapy at the IBD clinic of the TLVMC by a trained and qualified staff member. Each abdominal quadrant will receive a similar amount of time of exposure to the IR, except for the quadrant of the inflamed intestine (usually the right lower quadrant) which will be exposed longer to the IR. During the treatment, energy levels and skin temperature will be recorded at 10 minutes intervals. Patients responding to therapy (clinical response: ∆HBI≥3 and\u002For 50% reduction in calprotectin), who did not achieve remission can continue for 10 more treatments.",[13],"Device: High level photobiomodulation treatment in the infrared (IR) range.",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo arm","PLACEBO_COMPARATOR","Patients will undergo 10 sessions of 30 minutes of placebo treatment, at the IBD clinic of the TLVMC by a trained and qualified staff member. Each abdominal quadrant will receive a similar amount of time of exposure, except for the quadrant of the inflamed intestine (usually the right lower quadrant) which will be exposed longer. During the treatment, energy levels and skin temperature will be recorded at 10 minutes intervals.",[19],"Device: Photobiomodulation sham treatment",{"label":21,"type":10,"description":22,"interventionNames":23},"Low intensity fIR therapy","Patients will undergo 10 sessions of 30 minutes of low intensity (approximately 45˚C) fIR therapy at the IBD clinic of the TLVMC by a trained and qualified staff member. Each abdominal quadrant will receive a similar amount of time of exposure to the IR, except for the quadrant of the inflamed intestine (usually the right lower quadrant) which will be exposed longer to the IR. During the treatment, energy levels and skin temperature will be recorded at 10 minutes intervals. Patients responding to therapy (clinical response: ∆HBI≥3 and\u002For 50% reduction in calprotectin), who did not achieve remission can continue for 10 more treatments.",[24],"Device: Low level photobiomodulation treatment in the far infrared (IR) range",{"label":26,"type":10,"description":27,"interventionNames":28},"Medium intensity fIR therapy","Patients will undergo 10 sessions of 30 minutes of medium intensity (approximately 60˚C) fIR therapy at the IBD clinic of the TLVMC by a trained and qualified staff member. Each abdominal quadrant will receive a similar amount of time of exposure to the IR, except for the quadrant of the inflamed intestine (usually the right lower quadrant) which will be exposed longer to the IR. During the treatment, energy levels and skin temperature will be recorded at 10 minutes intervals. Patients responding to therapy (clinical response: ∆HBI≥3 and\u002For 50% reduction in calprotectin), who did not achieve remission can continue for 10 more treatments.",[29],"Device: Medium level photobiomodulation treatment in the far infrared (IR) range",[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","High level photobiomodulation treatment in the infrared (IR) range.","The baseline treatment included 10 weekly 30 minutes long sessions of high level fIR treatment.",[9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Medium level photobiomodulation treatment in the far infrared (IR) range","The baseline treatment included 10 weekly 30 minutes long session of medium level fIR treatments",[26],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Low level photobiomodulation treatment in the far infrared (IR) range","The baseline treatment included 10 weekly 30 minutes long session of low level fIR treatments",[21],{"type":32,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Photobiomodulation sham treatment","The baseline treatment includes 10 weekly 30 minutes long of sham fIR treatment.",[15],[50],{"name":51,"affiliation":52,"role":53},"Nitsan Maharshak, Professor","Department of Gastroenterology and Liver Diseases, Tel Aviv Medical Center, Tel Aviv, Israel","PRINCIPAL_INVESTIGATOR",[55,59],{"name":51,"role":56,"phone":57,"phoneExt":36,"email":58},"CONTACT","+972527360384","nitsanm@tlvmc.gov.il",{"name":60,"role":56,"phone":61,"phoneExt":36,"email":62},"Rony Izhar, PhD","+972504991116","ronyi@tlvmc.gov.il",[64],{"facility":65,"status":66,"city":67,"state":36,"zip":36,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center","RECRUITING","Tel Aviv","Israel","IL",{"type":71,"coordinates":72},"Point",[73,74],34.78057,32.08088,{"lat":74,"lon":73},[77,80,82],{"name":78,"role":56,"phone":79,"phoneExt":36,"email":58},"Nitsan Mahrshak, MD","972527360384",{"name":60,"role":56,"phone":81,"phoneExt":36,"email":62},"972504991116",{"name":83,"role":84,"phone":36,"phoneExt":36,"email":36},"Dorit Parnas, PhD","SUB_INVESTIGATOR",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"SPONSOR_INVESTIGATOR","Shmuel Kivity, MD","Professor","100527365","the-assessment-of-infrared-treatment-for-crohns-disease-100527365",false,"NCT06146816","The Assessment of Infrared Treatment for Crohn's Disease","An Exploratory Clinical Trial for the Assessment of Infrared Treatment for Crohn's Disease","Inclusion Criteria:\n\n1. An established Crohn's disease\n2. 18 \\\u003C age \\\u003C 80\n3. No therapy or on constant medicinal regimen throughout the study period: mesalamine at least 6 weeks, or steroids at least 2 weeks, or immunomodulatory drugs at least 12 weeks or biologics at least 12 weeks, medical cannabis at least 2 weeks before the study.\n4. CD patients will be included if their symptoms score \\>4 on the Harvey-Bradshaw index (HBI) score and\u002For fecal calprotectin level \\> 150 ug\u002Fgr.\n\nExclusion Criteria:\n\n1. BMI greater than 30 Kg\u002Fm2\n2. Any proven current infection such as Clostridioides difficile infection, positive stool culture, or parasites.\n3. Inability to sign informed consent and complete study protocol\n4. Pregnancy\n5. Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD.\n6. Presence of abscess and cysts in the liver\u002F kidneys or pancreas\n7. Evidence of an abdominal abscess or entero-enteric fistula.\n8. More than one CD luminal surgery or a small bowel length \\\u003C 1.5 meter","ALL","18 Years","80 Years",{"count":100,"type":101},40,"ESTIMATED","INTERVENTIONAL",[104],"NA","The goal of this clinical trial is to test the safety and efficacy of far Infra-red (fIR) therapy in Crohn's disease patients.\n\nThe main questions it aims to answer are:\n\n1. Is infrared therapy safe for treating Crohn's disease patients?\n2. Is infrared therapy effective for treating Crohn's disease?\n\nParticipants will be asked to attend 10 treatments of fIR therapy, provide stool and blood samples and answer questionnaires.\n\nResearchers will compare between 4 treatments: three intensities of fIR therapy and placebo treatment to explore which intensity is most effective for treating Crohn's disease.",[107,108,109],"IBD","Inflammatory Bowel Diseases","Crohn Disease",[111,112],"inflammation","Infra-red","2026-02-22",{"date":115,"type":116},"2026-02-24","ACTUAL",{"date":118,"type":116},"2023-09-12",{"date":120,"type":101},"2028-01",{"name":87,"class":6},1]