[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443763":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":27,"overallOfficials":35,"centralContacts":42,"locations":47,"responsibleParty":66,"collaborators":13,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":13,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":13,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":50,"whyStopped":13,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Michigan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Halitosis Associated Life-quality Test (HALT) questionnaire (modified)","Following the intervention, participants will answer questions regarding if their bad breath has improved over the course of the study compared to the starting point. The scores will be from 0 (no issue) - 5 (worst possible issue) for each question.","90 days (post-intervention)",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","This is a sub-study to the ongoing clinical trial entitled: Aquamin®, a multi-mineral natural product from red marine algae, as an adjuvant intervention for mild ulcerative colitis and ulcerative colitis in remission (HUM00156676) NCT# NCT03869905.\n\nHowever, the Food and Drug Administration (FDA) indicated that no Investigational New Drug Application (IND) was required.",[22],{"label":23,"type":24,"description":13,"interventionNames":25},"Aquamin®","EXPERIMENTAL",[26],"Drug: Aquamin",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Aquamin","Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium\u002Fday).",[23],[34],"Nutritional",[36,39],{"name":37,"affiliation":5,"role":38},"Muhammad N Aslam","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":5,"role":41},"Iwonka Eagle","STUDY_DIRECTOR",[43],{"name":37,"role":44,"phone":45,"phoneExt":13,"email":46},"CONTACT","734-936-1897","mnaslam@umich.edu",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University of Michigan School of Dentistry","RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-83.74088,42.27756,{"lat":60,"lon":59},[63],{"name":40,"role":44,"phone":64,"phoneExt":13,"email":65},"734-615-8507","ilenda@umich.edu",{"type":38,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Muhammad N Aslam, MD","Associate Research Scientist","100443763","phase-2-effectiveness-of-aquamin-in-mitigating-halitosis-100443763",false,"NCT05058638","Effectiveness of Aquamin® in Mitigating Halitosis","Evaluation of Halitosis Using a Multi-Mineral Approach (Aquamin®)","Inclusion Criteria:\n\n* Must be able to give written informed consent\n* Willing to follow study procedures of no eating, drinking, toothbrushing, smoking or using mouth rinse 60 minutes before study visits\n* Have stable oral health\n* Self-reported halitosis\n* A negative pregnancy test for pre-menopausal women with intact female reproductive organs, and the subject must agree to use appropriate birth control over the study period.\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Participating in any other interventional trials using an investigational drug\n* Diagnosed with any stomach or intestinal bleeding disorders (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin-secreting tumors) or active gastric\u002Fduodenal ulcers - peptic ulcer disease (in last 3 months) or with severe symptoms of ulcerative colitis or Crohn's disease\n* Any gastrointestinal or colonic malignancy; kidney disease, including kidney \"stones\" or hypercalcemia\n* Coagulopathy\u002Fhereditary hemorrhagic disorders\u002For receiving therapeutic doses of Coumadin or heparin\n* Have any severe oral condition that, in the opinion of the oral healthcare provide might impact the results of the study if the condition is treated\n* Have been treated for oral cancer within the past year\n* Taking any of the following within 30 days (will be eligible after completing 30 days of washout period):\n\nCalcium; Vitamin D, including multivitamins that have low amounts of calcium\u002FVitamin D supplements; Oral steroids; Non-steroidal anti-inflammatory medications (NSAIDS); Antibiotics.",true,"ALL","18 Years","99 Years",{"count":81,"type":82},25,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","The purpose of this study is to assess whether Aquamin®, a multi-mineral natural product from red marine algae, can help reduce halitosis when taken for 90 days.",[88,89],"Healthy","Halitosis",[23],"2026-08-25",{"date":93,"type":94},"2026-08-28","ACTUAL",{"date":96,"type":94},"2022-08-15",{"date":98,"type":82},"2027-12",{"name":5,"class":6},1]