[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ileal-pouch\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ileal-pouch":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100631469","phase-2-aquamin-for-prevention-of-ulcerative-colitis-j-pouch-associate-intestinal-inflammation-100631469",false,"NCT07501078","Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation","Inclusion Criteria:\n\n* Must be able to give written informed consent (or assent as appropriate)\n* Must have the following: UC with ileal pouch-anal anastomosis (IPAA) using a J-pouch without an ileostomy within the last eight months\n* For pre-menopausal women 11 years of age and older with intact reproductive organs, a negative pregnancy test is required within two weeks prior to the baseline visit. Participants in this age group must agree to use an acceptable form of contraception throughout the study per protocol.\n\nExclusion Criteria:\n\n* Female subjects must not be pregnant or lactating; and female of childbearing potential unwilling to use acceptable birth control throughout the study.\n* Must not be participating in any other interventional trial using an investigational drug.\n* Subjects likely to be uncooperative or unable to comply with study procedures\n* History or diagnosis of Crohn's disease\n* History or diagnosis of hereditary gastrointestinal (GI) syndromes, Severe gastrointestinal bleeding\u002Fcomplications, (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin-secreting tumors).\n* History or diagnosis of any gastrointestinal malignancy\n* Kidney disease, including kidney \"stones\" or hypercalcemia. acute renal failure (past 12 weeks). (Note: A doubtful stone passed in the urine more than three years ago is not considered evidence of current renal stone disease.)\n* Congenital coagulopathies or hereditary hemorrhagic disorders; treatment with therapeutic doses of warfarin or heparin\n* Participants will be excluded if they have used any of the following within the past 30 days or are unwilling to withdraw for 30 days prior to entering into the study:\n\n  * Calcium, Magnesium, including multivitamins that have low amounts of Calcium\u002FMagnesium and fiber supplements. (Multivitamins without any minerals are allowed).\n  * Non-steroidal anti-inflammatory medications (NSAIDs), such as Naproxen or Ibuprofen (except for occasional pain control or low dose aspirin for cardiovascular disease prevention) per protocol.\n  * Oral or rectal Corticosteroids (a type of steroid drug such as prednisone or cortisol that helps the body to regulate stress response, immune response and inflammation) and antibiotics (except these can be used briefly during a flare-up once the study treatment has begun after the subject enrolled, if prescribed by the personal physician). Inhaled and skin corticosteroids preparations are ok and not an exclusion criteria.","ALL","5 Years","80 Years",{"count":19,"type":20},52,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Ulcerative colitis (UC) is a disease that causes long-term inflammation in the digestive tract, and many people with this condition require surgery to remove the colon and create a new J-pouch for stool. Some patients develop a problem called pouchitis, where this pouch becomes inflamed. Current treatments are limited, and there are no known ways to prevent pouchitis from starting. This study is being done to find out if a natural mineral supplement called Aquamin® can help reduce inflammation and protect the gut lining in people with a J-pouch, and may reduce the risk of pouchitis. By understanding whether Aquamin® is safe and helpful, the study team hopes to find a new and better way to prevent inflammation and improve the long-term health of people with UC.",[26,27],"Ulcerative Colitis","Ileal Pouch",[29,30,31,32,33,34],"J-pouch without an ileostomy","Surveys","Sample collection","Placebo","Aquamin®","Randomization","RECRUITING","2026-06-25",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":20},"2026-07",{"date":43,"type":20},"2029-05",{"name":45,"class":46},"Muhammad N Aslam, MD","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100511363","phase-1-study-of-exe-346-live-biotherapeutic-to-reduce-high-bowel-movement-frequency-in-subjects-with-an-ipaa-prof-100511363","NCT05938465","Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)","A Phase 1b\u002F2 Study to Demonstrate the Safety and Efficacy of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an Ileal Pouch-Anal Anastomosis (PROF). The \"PROF\" Study.","PROF","Inclusion Criteria - Phase 1b Only\n\n1. Subject is a male or female and is between the age of 18 to 70 years, inclusive, at screening.\n2. Subject has had a documented pouchoscopy within 12 months prior to screening.\n3. Subject or the subject's legally authorized representative is willing and able to provide written informed consent prior to the initiation of any study-related procedures.\n4. Subject has an average daily bowel movement frequency of at least 10 bowel movements recorded during screening and has correctly completed at least 7 days of eDiary entries during the screening period (Days -13 to 0).\n\nInclusion Criteria - Phase 2 Double-Blinded Part Only\n\n1. Subject is a male or female and is aged 18 years or older at screening.\n2. Subject is willing and able to provide written informed consent prior to the initiation of any study-related procedures.\n3. Subject has an average daily bowel movement frequency of at least 10 bowel movements recorded during screening and has correctly completed at least 7 days of eDiary entries during the screening period (Days -21 to 0).\n\nInclusion Criteria - Both Phase 1b and Phase 2 Double-Blinded Parts\n\n1. Subject has had an IPAA for at least 6 months prior to screening.\n2. Female subjects of childbearing potential must have a negative serum pregnancy test result at screening and must not be lactating and\u002For breastfeeding.\n3. Subjects (female subjects of childbearing potential and male subjects with partners of childbearing potential) must agree to use proper contraceptive methods (see Section 13.2 for contraceptive guidance) to avoid pregnancy during the study. Nonchildbearing potential is defined as at least 6 weeks after a hysterectomy with or without surgical bilateral oophorectomy or postmenopausal (at least 12 months since natural amenorrhea).\n\nInclusion Criteria - Optional Open-Label Extension Phase Only\n\n1. Subjects must have completed the Phase 2 double-blinded part of the study and are willing to participate in the optional open-label extension phase.\n\n   Note: Subjects who discontinued study treatment in the Phase 2 double-blinded part but who have remained in the study for safety monitoring are eligible for continued safety monitoring in the optional open-label extension phase; however, study treatment will not be re-started in such subjects.\n2. Subjects must understand the study procedures, the risks involved, and are willing to continue to adhere to the study visit\u002Fprotocol schedule.\n\nExclusion Criteria Subjects meeting any of the criteria specified below for the study phase in which they are enrolling will be excluded from the study.\n\nExclusion Criteria - Phase 1b Only\n\n1. Subject has Crohn's-like disease of the pouch, as indicated by their most recent pouchoscopy during the 12 months prior to screening.\n2. Subject has a stricture of the IPAA or afferent limb stricture, as indicated by their most recent pouchoscopy during the 12 months prior to screening.\n3. Subject has taken biologics, azathioprine, or methotrexate within the 12 weeks prior to screening or systemic steroids within 4 weeks of screening.\n4. Subject has a positive reverse transcriptase-PCR diagnostic test for SARS-CoV-2 within the 14 days prior to screening.\n5. Subject has uncontrolled hypertension (systolic pressure \\>160 mm Hg or diastolic pressure \\>95 mm Hg on at least 2 measures performed at least 10 minutes apart) at screening.\n\nExclusion Criteria - Phase 2 Double Blinded Part Only\n\n1. Subject has Crohn's-like disease of the pouch, as indicated by the pouchoscopy conducted during study screening.\n2. Subject has isolated severe cuffitis without pouch inflammation (endoscopic mPDAI score of 2 or lower), as indicated by the pouchoscopy conducted during study screening.\n3. Subject has a clinically significant stricture of the IPAA or afferent limb stricture which requires surgery or recurrent dilations more than every 3 months, as indicated by the pouchoscopy conducted during study screening. Subjects who have a planned dilation during the active study period are excluded (dilation during the screening pouchoscopy is allowed).\n4. Subject has taken biologics, azathioprine, methotrexate or small molecules (e.g., JAK inhibitors, S1P receptor modulators) within the 12 weeks prior to screening or systemic steroids within 4 weeks prior to screening.\n5. Subject has a positive reverse transcriptase-PCR diagnostic test for SARS-CoV-2 within the 7 days prior to screening, per subject self report.\n6. Subject has an average daily bowel movement frequency of \\>25 bowel movements recorded during the screening period (Days -21 to 0).\n7. Subject is taking opioid therapy as a long-term treatment or has taken opioids within 2 weeks prior to screening.\n8. Subject has taken probiotics within 2 weeks prior to screening.\n9. Subject has previously received EXE-346 for any duration. Subjects who participated in Phase 1b are excluded from Phase 2.\n10. Subject has a concurrent, clinically significant, serious, unstable or uncontrolled medical or psychiatric condition that, in the opinion of the investigator, might confound study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study.\n\nExclusion Criteria - Both Phase 1b and Phase 2 Double-Blinded Part\n\n1. Subject has enterocutaneous or recto- or pouch-vaginal fistula.\n2. Subject has active Clostridium difficile infection.\n3. Subject has known or suspected active CMV infection.\n4. Subject initiated a new treatment with antibiotics or antimotility therapies within the 2 weeks prior to screening or plans to start a new or change doses of a current treatment during the study period (screening visit through the safety follow-up visit \\[Day 57 in the Phase 1b part or Day 71 in the Phase 2 part\\]). Subjects taking antibiotics to treat antibiotic-dependent pouchitis or antidiarrheal medication are eligible for the study provided they have been on the therapy at a stable dose for at least 2 weeks prior to screening.\n5. Subject is taking NSAIDs as a long-term treatment (ie, consistent use for at least 4 days\u002Fweek each month). Acute use of NSAIDs is allowed.\n6. Subject has a known history or positive test during screening for HIV, HIV-1, HIV-2, or active HBV or HCV. Active HCV infection is defined as a subject with a positive hepatitis C antibody and detectable hepatitis C viral load RNA.\n7. Subject has a history of malignancy within the 5 years prior to screening, with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia, or treated in situ grade 1 cervical cancer.\n8. Subject has estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m2 at screening.\n9. Subject has known hypersensitivity to EXE-346 or any product components.\n10. Female subject is pregnant or lactating and\u002For breastfeeding.\n11. Subject has participated in any clinical study of an approved or nonapproved investigational medicinal product within the 30 days prior to screening.\n12. Subject has any disorder that, in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol, including but not limited to:\n\n    1. Decompensated liver disease\n    2. Elevation of AST, ALT, or bilirubin \\>2 × ULN\n    3. Primary sclerosing cholangitis with elevated transaminases\n\nExclusion Criteria - Optional Open-Label Extension Phase Only\n\n1\\. Subjects who have developed any medical or psychologic condition, which was excluded in the Phase 2 double-blinded part of the study or in the opinion of the investigator and\u002For medical monitor might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.","18 Years",{"count":58,"type":20},50,[60,23],"PHASE1","The aim of this study is to assess the safety and preliminary efficacy of treatment with EXE-346, a live biotherapeutic, which may reduce bowel movement frequency in patients with an ileal pouch-anal anastomosis (IPAA) and lead to a higher quality of life.",[27],[64,65,66,67],"Pouchitis","Pouch","Ileal Pouch Anastomosis","IPAA","2026-05-26",{"date":70,"type":39},"2026-05-28",{"date":72,"type":39},"2023-11-06",{"date":74,"type":20},"2027-07-31",{"name":76,"class":77},"Exegi Pharma, LLC","INDUSTRY",8]