[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659720":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":27,"studyPopulation":17,"armGroups":28,"interventions":43,"overallOfficials":17,"centralContacts":56,"locations":66,"responsibleParty":84,"collaborators":87,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":17,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":17,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":116,"whyStopped":17,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Colorado State University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Gastrointestinal Symptom Rating Scale (GSRS)","The Gastrointestinal Symptom Rating Scale (GSRS) is a widely used tool for measuring gastrointestinal symptoms across five domains. The GSRS is scored between \"No discomfort\" and \"Very severe discomfort\"","4 weeks",[14],{"measure":15,"description":16,"timeFrame":12},"Tumor Necrosis Factor Alpha","Tumor necrosis factor alpha, or TNF-a, is an inflammatory cytokine that is implicated in many diseases.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","CROSSOVER","SUPPORTIVE_CARE",{"masking":23,"maskingDescription":17,"whoMasked":24},"DOUBLE",[25,26],"PARTICIPANT","INVESTIGATOR","This study will take place at Colorado State university in Fort Collins, Colorado, USA. It will last approximately 17 weeks. This is a randomized, double-blind 3-arm crossover study with three treatments (placebo and two doses of Pichia kluyveri). The treatments will be taken for 4 weeks in a random order by every participant. Each treatment phase is separated by a 2-week washout. The first visit is a screening visit, where we will determine eligibility. Visit 2-7 are test visits where we will complete height, weight, waist, and hip measurements. blood pressure measurements, and a blood draw. You will also complete questionnaires about your gut, mental, and skin health, menopause symptoms, and physical activity. You will also collect stool samples and complete bowel movement and diet records at home.",[29,34,38],{"label":30,"type":31,"description":17,"interventionNames":32},"Pichia kluyveri 9.9 x 10^7","EXPERIMENTAL",[33],"Dietary Supplement: 9.9 x 10^7 Pichia kluyveri PK88",{"label":35,"type":31,"description":17,"interventionNames":36},"Pichia kluyveri 1 x 10^8",[37],"Dietary Supplement: 1 x 10^8 Pichia kluyveri PK88",{"label":39,"type":40,"description":17,"interventionNames":41},"Placebo","PLACEBO_COMPARATOR",[42],"Dietary Supplement: Placebo",[44,49,53],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":17},"DIETARY_SUPPLEMENT","9.9 x 10^7 Pichia kluyveri PK88","9.9 x 10\\^7 Pichia kluyveri in microcrystalline cellulose and hypromellose",[30],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":17},"1 x 10^8 Pichia kluyveri PK88","1 x 10\\^8 Pichia kluyveri in microcrystalline cellulose and hypromellose",[35],{"type":45,"name":39,"description":54,"armGroupLabels":55,"otherNames":17},"Placebo - cellulose and hypromellose",[39],[57,62],{"name":58,"role":59,"phone":60,"phoneExt":17,"email":61},"Tiffany L Weir, PhD","CONTACT","970-215-7571","tiffany.weir@colostate.edu",{"name":63,"role":59,"phone":64,"phoneExt":17,"email":65},"Jenny Whittington, MS","970-310-6843","ijwhitt@rams.colostate.edu",[67],{"facility":5,"status":17,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Fort Collins","Colorado","80521","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-105.08442,40.58526,{"lat":77,"lon":76},[80,82],{"name":81,"role":59,"phone":60,"phoneExt":17,"email":61},"Tiffany Weir, PhD",{"name":81,"role":83,"phone":17,"phoneExt":17,"email":17},"PRINCIPAL_INVESTIGATOR",{"type":83,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Tiffany Weir","Professor",[88],{"name":89,"class":90},"Biohm Technologies","INDUSTRY","100659720","exploration-of-tolerability-and-dose-responses-for-a-yeast-based-probiotic-100659720",false,"NCT07867496","Exploration of Tolerability and Dose Responses for a Yeast-based Probiotic","Inclusion Criteria:\n\n* between 18-75 years old\n* BMI \\\u003C30 kg\u002Fm2\n* mild\u002Fmoderate gastrointestinal distress\n\nExclusion Criteria:\n\n* Have taken antibiotics within two months of enrollment in the study\n* Are currently taking statins, metformin, NSAIDs, and MAO inhibitors or other medications that could interfere with study outcomes, as determined by the study PI\n* Have a current diagnosis of cancer, liver or kidney disease, gastrointestinal diseases (including Celiac, Crohn's, Ulcerative Colitis), and cardiometabolic disorders (cardiovascular disease, diabetes, etc.)\n* Are pregnant or breastfeeding, or actively trying to lose weight\n* Use excessive alcohol\n* Use of supplements containing probiotics at any dose or if you are participating in other studies that may interfere with the bacteria in your gut.\n* Unable or unwilling to consume capsules, provide stool or blood samples, track bowel movements and symptoms, and attend scheduled clinic visits.\n* Have allergies to study treatments or medical supplies (eg. Latex, yeast, cellulose)",true,"ALL","18 Years","75 Years",{"count":102,"type":103},50,"ESTIMATED","INTERVENTIONAL",[106],"NA","The purpose of this study is to evaluate the tolerability and efficacy of a yeast-based dietary supplement on gastrointestinal, mental, and skin health. Yeasts are naturally present on fruits and plants, and are used to bake bread, beer and wine. Some of these yeasts are commonly consumed and may actually benefit your gut health. The supplemental yeast could strengthen your gut lining or help good bacteria in your gut grow better.\n\nIn this study, we will look at how two doses of a yeast-baaed supplement impacts your gut health, your bowel movement consistency, your and mental health. the study will last 17 weeks and consist of 7 clinic visits (1 screening visit and 6 test visits).",[109,110],"Healthy Adult Participants","Gut Health",[112,113,114,115],"Probiotic","Gut health","Dietary Supplement","Yeast-based Probiotic","NOT_YET_RECRUITING","2026-10-05",{"date":119,"type":120},"2026-10-09","ACTUAL",{"date":122,"type":103},"2026-11-01",{"date":124,"type":103},"2028-03-01",{"name":5,"class":6},1]