[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ulcerative-colitis-chronic-moderate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ulcerative-colitis-chronic-moderate":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,72,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100490502","phase-1-r-3750-in-patients-with-mild-to-moderate-ulcerative-colitis-100490502",false,"NCT05666960","R-3750 in Patients With Mild to Moderate Ulcerative Colitis","A Single and Repeat Dosing Study of the Safety, Drug Exposure, and Clinical Activity of R-3750 in Patients With Mild to Moderate Ulcerative Colitis","INCLUSION CRITERIA:\n\n* 18-65 years of age\n* Ability to provide written informed consent\n* Confirmed diagnosed with UC by colonoscopy and histology and suffering from mild to moderate UC as defined by MMDAI with score of 3-9\n* On a stable dose of aminosalicylate (i.e. no change in medication within 4 weeks of study enrollment) and not planning to initiate new medication other than the study drug\n* For women of childbearing potential or men with a partner of childbearing potential, agree to use birth control methods (including hormonal contraceptives, intrauterine device (IUD) or hormone releasing system (IUS), vasectomy) and men will refrain from donating sperm during the study and at least 30 days after dosing (per FDA guidelines)\n* For the expansion cohort, a flexible sigmoidoscopy is required, unless an endoscopy was completed within 3 months from enrollment is available\n* Refrain from receiving any type of vaccinations during the study period (to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio)\n\nEXCLUSION CRITERIA:\n\n* Pregnancy, planned pregnancy, breastfeeding women\n* Evidence of severe UC disease (MMDAI score greater than or equal to 10)\n* Evidence of any active or recent infection including chronic infectious disease such as Hepatitis B, C, or HIV\n* Evidence of any active or recent chronic chest infection with bronchiectasis or sinusitis, or covid-19 infection in the past 3 months\n* Treatment with immunosuppressants or anti-cancer drugs, e.g., anti-TNF-α agents, anti-integrin agents, azathioprine or 6-MP, 6-thioguanine, methotrexate, ozanimod, tofacitinid, upadacitinib, tacrolimus, cyclophosphamide, or cyclosporine or any other therapy that is not an aminosalicylate within the last 3 months\n* Received an investigational drug within 3 months (or 5 half-lives, whichever is longer) before study entry\n* Use of steroidal drugs to treat UC (e.g., prednisone \\>20 mg\u002Fday)\n* Use of probiotics within the last one (1) week and during the trial.\n* Treatment with systemic broad-spectrum antibiotics in the past 2 months\n* Major active systemic autoimmune disease other than UC\n* History of anaphylaxis or allergies to probiotics\n* History of alcohol or drug abuse within the past 2 years\n* History of stroke, or any cerebrovascular disease requiring medication\u002Ftreatment\n* History of cancer, apart from successfully treated basal cell carcinoma or in situ carcinoma of the cervix \\>1 year prior to enrollment\n* Significant laboratory abnormalities, including liver transaminases (AST or ALT) \\> 1.5X the upper limit of normal.\n* Second degree or higher heart block or clinically significant arrythmia\n* Any other clinically significant renal, hepatic, hematological or other disease or laboratory abnormality which, in the opinion of the investigator, would interfere with the conduct, the interpretation of the safety signals or results of the trial, or would place the subject at unacceptable risk\n* Any condition or circumstance that, in the opinion of the Principal Investigator, would compromise the safety of the subject or the quality of study data","ALL","18 Years","65 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate ulcerative colitis.\n\nPatients will take an oral dosage of probiotic (R-3750) and provide patient-reported and physician scored measures of their colitis. Blood and fecal evaluations of inflammation and assessment of probiotic (R-3750) on fecal levels will also be measured.",[27,28,29,30],"Ulcerative Colitis Chronic Mild","Ulcerative Colitis Chronic Moderate","Ulcerative Colitis Chronic","Ulcerative Colitis",[32],"Colitis","RECRUITING","2026-06-10",{"date":36,"type":37},"2026-06-12","ACTUAL",{"date":39,"type":37},"2023-02-27",{"date":41,"type":21},"2026-10",{"name":43,"class":44},"Rise Therapeutics LLC","INDUSTRY",5,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100548399","phase-2-study-of-novel-therapeutics-for-acute-remedy-of-colitis-100548399","NCT06420492","Study of Novel Therapeutics for Acute Remedy of Colitis","SHARC","Inclusion Criteria:\n\n* Severe outpatient or hospitalized for an acute UC flare\n* Ability to give consent\n* Patients with a confirmed diagnosis of UC for \\> 3 months\n* History of ≥ 15 cm of colonic involvement as confirmed by colonoscopy\n* Patients with primary sclerosing cholangitis are eligible to enroll\n* Patients will have failed 5 days of oral prednisone 30 mg or greater for 5 days and still having a SCCAI of \\> 6\n* Patients who are taking 20mg or less of oral prednisone and plan to stay at that dose during their participation in the study\n* Accepted medications:\n\n  * Anti-TNF agents are permissible if the patient has been taking them for at least 10 weeks and anticipates to maintain a steady for the duration of the study.\n  * Rinvoq (Upadacitinib) is permissible if the subject has been taking this medication for at least 4 weeks and anticipates to maintain a steady dose for the duration of the study.\n  * Xeljanz (Tofacitinib) is permissible if the subject has been taking this medication for at least 4 weeks and anticipates to maintain a steady dose for the duration of the study.\n  * Other biologics are permissible if the subject has been taking the medication for at least 10 weeks and anticipates to maintain a steady dose for the duration of the study\n\nExclusion Criteria:\n\n* History of uncontrolled hypertension with systolic BP \\> 140 and systolic BP \\> 90\n* Chronic kidney disease as defined by GFR \\\u003C55mL\u002Fmin\n* Impaired hepatic function (transaminases elevated \\> 2.5 x ULN) unless due to PSC\n* Evidence of C. difficile (Negative test result within 1 month is acceptable)\n* Infectious Colitis or drug induced colitis\n* Crohn's Disease or Indeterminate colitis\n* Decompensated liver disease\n* Patients who are pregnant or breastfeeding\n* Patients who have a confirmed malignancy or cancer within 5 years\n* Congenital or acquired immunodeficiencies\n* Other comorbidities including: Diabetes mellitus, systemic lupus\n* Participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trial\n* Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease\n* Prohibited medications:\n\n  * Rinvoq (Upadacitinib): Subjects will be excluded from this study if their last dose of this medication was administered within 4 weeks. If subjects have stopped taking this medication and their last dose was administered more than 4 weeks prior to enrollment, they will be eligible for participation.\n  * Xeljanz (Tofacitinib): Subjects will be excluded from this study if their last dose of this medication was administered within 4 weeks. If subjects have stopped taking this medication and their last dose was administered more than 4 weeks prior to enrollment, they will be eligible for participation.\n  * Other Medications: Subjects will be excluded from this study if they stopped taking any other medications for ulcerative colitis within 8 weeks. If subjects have stopped taking the medication and their last dose was more than 8 weeks prior to enrollment, they will be eligible for participation.","75 Years",{"count":55,"type":21},20,[57],"PHASE2","This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with acute ulcerative colitis. Patients who qualify are adults who have not responded to treatments for their severe ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as an open-label pilot study in which participants will take the study drug for 4 weeks in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 8 study visits, all of which will be conducted at a study site. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool and urine sample for a few lab tests throughout the study. Participants may also undergo a flexible sigmoidoscopy at the beginning and end of the study.",[30,28,60],"Ulcerative Colitis Chronic Severe","2025-10-15",{"date":63,"type":37},"2025-10-20",{"date":65,"type":37},"2025-09-30",{"date":67,"type":21},"2027-06-01",{"name":69,"class":70},"Brigham and Women's Hospital","OTHER",2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":18,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":102},"100500071","combination-of-diet-and-oral-budesonide-for-ulcerative-colitis-100500071","NCT05791487","Combination of Diet and Oral Budesonide for Ulcerative Colitis","Remission With Diet for Ulcerative Colitis Exacerbations: A Single Blinded, International Randomized Controlled Clinical and Translational Trial","ReDUCE","Inclusion Criteria:\n\n* Informed consent\n* Established diagnosis of UC with mild to moderate active disease, 5 ≤ SCCAI ≤ 10\n* Age: 17-65 years (inclusive)\n* Extent E1-E3 by the Montreal classification\n* Active colitis in the rectum or sigmoid colon on sigmoidoscopy\n* Stable medication use of oral 5ASA for at least 8 weeks, thiopurines, vedolizumabs, Ustekinumab or tofacitinib for at least 12 weeks\n\nExclusion Criteria:\n\n* Severe colitis (SCCAI\\>10) hospitalization for acute severe colitis (ASC) in the previous 6 months\n* Use of steroids in the previous 3 months\n* Patients treated with Anti-TNF currently or in patients who had previously failed or lost response to anti TNF\n* Vegans (vegetarians may enroll)\n* Pregnancy\n* Inability use of budesonide due to severe adverse events\n* Extraintestinal manifestations such as arthritis, spondyloarthropathy or uveitis\n* Presence of baseline hypoalbuminemia\n* Fever \\>38°C\n* Evidence for Clostridioides difficile infection\n* Renal failure\n* Hepatitis or PSC (Primary Sclerosing Cholangitis)\n* Active malignancy (excluding skin BCC).","17 Years",{"count":82,"type":21},90,[84],"NA","The ReDUCE Trial is a multinational single-blinded randomized controlled trial in mild to moderate flare of Ulcerative colitis (UC) disease patients. The purpose of the study is to validate the clinical efficacy of the UCED (Ulcerative colitis Exclusion Diet) with partial enteral nutrition (PEN) using a novel formula.\n\nThe investigators anticipate that adding a novel specifically designed dietary intervention in addition to drug will lead to superior remission and mucosal healing via changes in the microbiome.",[30,27,28],[88,89,90,91],"Ulcerative colitis","Diet","Partial enteral nutrition","Microbiome","2024-05-21",{"date":94,"type":37},"2024-05-23",{"date":96,"type":37},"2023-12-01",{"date":98,"type":21},"2026-09-01",{"name":100,"class":101},"Wolfson Medical Center","OTHER_GOV",6,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100539998","understanding-ozanimods-moa-via-mass-cytometry-in-ulcerative-colitis-100539998","NCT06311123","Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis","High Dimensional Mass Cytometry as a Tool to Understand Ozanimod's Mechanism of Action (MOA)","Inclusion Criteria:\n\n1. Male or female patients aged 18 or older.\n2. Have had UC diagnosed at least 3 months prior to screening. The diagnosis must be confirmed by endoscopic and histologic evidence.\n3. Have active UC confirmed on endoscopy.\n4. Ability to provide written informed consent to IBD biobank (UCSD)\n5. Patients with above criteria being considered for ozanimod therapy and will not be treated in conjunction with biologics.\n\nExclusion Criteria:\n\n1. Have severe IBD as evidenced by:physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline\n2. Current evidence of fulminant colitis, toxic megacolon or bowel perforation\n3. Previous total colectomy\n4. Platelet count\\\u003C100,000\u002FμL\n5. Have positive stool culture for pathogens (O+P, bacteria) or positive test for C. difficile at screening. If C. difficile is positive, the patient may be treated and retested.\n6. Prisoners or subjects involuntarily detained will not be included.",{"count":111,"type":21},10,"OBSERVATIONAL","The goal of this observational study is to learn about the mechanism of action of ozanimod in patients with ulcerative colitis (UC). The main questions it aims to answer are:\n\n1. Prospectively assess the effects of ozanimod on the cellular composition of intestinal lamina propria and blood by deep immunophenotyping (CyTOF) of immune cell subsets prior and after the drug's administration.\n2. Determine whether changes in cell subsets observed via mass cytometry correlate with with clinical or histologic parameters of disease activity.\n\nColonic biopsies and peripheral blood samples will be collected from patients with UC before and after the onset of ozanimod.\n\nResearchers will compare intestinal and peripheral leukocytes before and after the drug's administration.",[30,28],[116,117,118],"colitis","ozanimod","mass cytometry","2024-03-07",{"date":121,"type":37},"2024-03-15",{"date":123,"type":37},"2023-10-06",{"date":125,"type":21},"2026-09-30",{"name":127,"class":70},"University of California, San Diego",1]