[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656790":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":63,"studyPopulation":55,"armGroups":64,"interventions":77,"overallOfficials":87,"centralContacts":92,"locations":98,"responsibleParty":112,"collaborators":55,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":55,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":55,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":100,"whyStopped":55,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Daily Nouri","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"Change in PROMIS Gastrointestinal Gas and Bloating Scale T-score from baseline to week 8","Participants rate each item on a 5-point frequency scale (Never, Rarely, Sometimes, Often, Always) reflecting the past 7 days","From baseline to week 8 assessment",[14,17,20,23,26,29,33,36,40,43],{"measure":15,"description":11,"timeFrame":16},"Change in PROMIS Gastrointestinal Gas and Bloating Scale T-score from baseline to week 4","From baseline to week 4 assessment",{"measure":18,"description":11,"timeFrame":19},"Change in PROMIS Gastrointestinal Belly Pain, Constipation, and Diarrhea T-scores from baseline to weeks 4 and 8","From baseline to week 4 and 8 assessments",{"measure":21,"description":22,"timeFrame":12},"Change in PROMIS Fatigue Short Form T-scores from baseline to week 8","Participants respond to 4 items about the past 7 days using a 5-point scale (Not at all, A little bit, Somewhat, Quite a bit, Very much).",{"measure":24,"description":25,"timeFrame":12},"Change in PROMIS Sleep Disturbance Short Form T-scores from baseline to week 8","Participants respond to 4 items about the past 7 days using 5-point response scales that vary by item (e.g., Very good\u002FGood\u002FFair\u002FPoor\u002FVery poor for sleep quality; Not at all\u002FA little bit\u002FSomewhat\u002FQuite a bit\u002FVery much for other items).",{"measure":27,"description":28,"timeFrame":12},"Change in WHO-5 Well-being Index from baseline to week 8","Participants respond to 5 items about the past two weeks using a 6-point scale (All of the time, Most of the time, More than half of the time, Less than half of the time, Some of the time, At no time), each scored 0 to 5.",{"measure":30,"description":31,"timeFrame":32},"Stool Frequency","Number of bowel movements per week, self-reported via weekly diary","Baseline to Week 8 (assessed weekly)",{"measure":34,"description":35,"timeFrame":32},"Bristol Stool Form Scale","A 7-point ordinal scale classifying stool consistency. Scores range from 1 (separate hard lumps) to 7 (watery, no solid pieces); types 3-4 are considered typical. Classification scale, not directional.Unit of Measure: Scores on a scale (1-7)",{"measure":37,"description":38,"timeFrame":39},"Urgency Episodes","Number of self-reported episodes of bowel urgency per week, captured via weekly diary. Unit of Measure: Episodes per week","From baseline to week 8 (assessed weekly)",{"measure":41,"description":42,"timeFrame":39},"Bloating Severity","Self-reported bloating severity over the past week, captured via weekly diary. Scored 0-10, with higher scores indicating greater bloating severity. Unit of Measure: Units on a scale (0-10, higher scores indicate greater bloating severity)",{"measure":44,"description":45,"timeFrame":46},"Product Perception Questionnaire","Participant-reported product experience and perception, assessed via a researcher-developed questionnaire covering product experience (ease of routine integration, ease of swallowing, gastric tolerability), perceived benefit across digestion, regularity, bloating, mood, energy, sleep, and skin, overall satisfaction and repurchase intent, and dosing pattern. Items are rated on a 5-point agreement scale (Strongly disagree, Disagree, Neither agree nor disagree, Agree, Strongly agree), except the dosing-pattern item, which is multiple choice.","Weeks 4 and 8",[48],{"measure":49,"description":50,"timeFrame":51},"Change in Automated Skin Appearance Parameters","At baseline and Week 8, participants capture a facial photograph within the study application following standardized on-screen guidance (front-facing, neutral expression, indirect daylight, no makeup). Images are analyzed by a contracted automated image analysis service that returns quantitative skin appearance parameters on a continuous 0 to 100 scale, with 0 representing the most pronounced visible presentation of the parameter and 100 representing the least visible presentation (i.e., a more favorable appearance). Pre-specified parameters are acne, redness, pigmentation, lines, and skin uniformity. These are image-derived appearance measures, not clinical or diagnostic assessments.","Baseline to Week 8",{"allocation":53,"interventionModel":54,"interventionModelDescription":55,"primaryPurpose":56,"observationalModel":55,"timePerspective":55,"maskingInfo":57},"RANDOMIZED","PARALLEL",null,"OTHER",{"masking":58,"maskingDescription":55,"whoMasked":59},"TRIPLE",[60,61,62],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a randomized, double-blind, placebo-controlled, decentralized clinical trial evaluating a commercially available multi-strain probiotic dietary supplement for its effects on gastrointestinal comfort and general well-being in healthy women.\n\nAll study procedures are conducted remotely through a secure digital research platform, including electronic informed consent, screening, questionnaire completion, supplement compliance tracking, and adverse event reporting. Participants complete a brief weekly diary of bowel habits and a fuller set of questionnaires at baseline, Week 4, and Week 8 covering gastrointestinal symptoms, psychological well-being, sleep, and fatigue. A facial photograph is also collected at baseline and Week 8 as part of an exploratory assessment of skin appearance.\n\nThe primary comparison of interest is the change in self-reported gas and bloating symptoms from baseline to Week 8 between the probiotic and placebo groups.\n\nThis study evaluates the product's effect on gastrointestinal comfort and general well-being in healthy adults; it is not designed to evaluate the diagnosis, treatment, or management of any disease.",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"Probiotic Supplement","EXPERIMENTAL","The study product is a commercially available multi-strain probiotic dietary supplement containing a blend of probiotic strains. Participants take one capsule by mouth daily, with or without food, for 8 weeks.",[70],"Dietary Supplement: Active: Multi-strain probiotic dietary supplement",{"label":72,"type":73,"description":74,"interventionNames":75},"Placebo","PLACEBO_COMPARATOR","The placebo is manufactured to be visually identical to the active study product in appearance, size, color, weight, and packaging, but contains no active ingredients. Participants take one capsule by mouth daily, with or without food, for 8 weeks.",[76],"Dietary Supplement: Placebo: Placebo",[78,83],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":55},"DIETARY_SUPPLEMENT","Active: Multi-strain probiotic dietary supplement","A capsule-in-capsule dietary supplement containing a seven-strain probiotic blend (12 billion CFU per capsule), taken once daily.",[66],{"type":79,"name":84,"description":85,"armGroupLabels":86,"otherNames":55},"Placebo: Placebo","A capsule-in-capsule placebo manufactured to be visually identical to the active study product in appearance, size, color, weight, and packaging, containing no active ingredients, taken once daily.",[72],[88],{"name":89,"affiliation":90,"role":91},"Barbara A Davis, PhD, RD","Ingredient Factor, LLC","PRINCIPAL_INVESTIGATOR",[93],{"name":94,"role":95,"phone":96,"phoneExt":55,"email":97},"Alethios","CONTACT","650-206-8006","support@alethios.com",[99],{"facility":94,"status":100,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":55},"RECRUITING","San Francisco","California","94109","United States","US",{"type":107,"coordinates":108},"Point",[109,110],-122.41942,37.77493,{"lat":110,"lon":109},{"type":113,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","100656790","multi-strain-probiotic-supplement-for-digestive-comfort-and-well-being-in-healthy-women-100656790",false,"NCT07831317","Multi-strain Probiotic Supplement for Digestive Comfort and Well-being in Healthy Women","Effects of a Multi-Strain Probiotic Supplement on Gastrointestinal Comfort and General Well-Being in Women: A Randomized, Double-Blind, Placebo-Controlled, Decentralized Study","Inclusion Criteria:\n\n* Self-reported gas and\u002For bloating occurring on 4 or more days per week for at least the past 6 months\n* Mild-to-moderate ongoing gastrointestinal symptoms at screening, defined as a PROMIS Gastrointestinal Gas and Bloating Scale T-score of 55 to 69, inclusive\n* Body mass index (BMI) 18.5 to 32.5 kg\u002Fm2 (inclusive)\n* Self-reported symptoms of hormonal imbalance within the past 3 months, including at least one of the following: irregular or unpredictable menstrual cycles, acne, excess facial or body hair growth, or scalp hair thinning\n* If using psychotropic medication (including antidepressants, anxiolytics, mood stabilizers, or stimulants): stable medication and dose for at least three months prior to screening, with no anticipated changes during the study; medication name, dose, and start date recorded at screening\n* If using hormonal contraception: stable method for at least three months prior to screening, with no anticipated changes during the study; method and start date recorded at screening\n* Willing to abstain from all other probiotic and prebiotic supplements and probiotic-fortified functional foods from screening through study completion\n* Willing and able to maintain consistent diet, physical activity, and medication habits for the duration of the study\n* Willing and able to provide electronic informed consent and comply with the protocol\n* Resident of the United States with access to a smartphone with internet access and a functioning front-facing or rear camera, to allow completion of all online instruments and the skin health selfie assessment\n* Able to read and understand English at the 6th-grade level\n\nExclusion Criteria:\n\n* Current use of a GLP-1 receptor agonist of any class or type, or use within the 3 months prior to screening\n* Use of any probiotic or prebiotic dietary supplement within the 4 weeks prior to screening\n* Use of systemic antibiotics within the 4 weeks prior to screening, or anticipated use during the study\n* Diagnosed gastrointestinal disease or disorder, including inflammatory bowel disease (Crohn's disease, ulcerative colitis), celiac disease, gastroparesis, gastrointestinal malignancy, or prior bariatric or other major gastrointestinal surgery\n* Current or past diagnosis of endometriosis or a thyroid or other endocrine\u002Fgynecological disorder, whether or not currently controlled\n* Chronic or serious medical conditions, including uncontrolled cardiovascular, metabolic, neurologic, immune (including immunocompromised states), renal, or hepatic disease, or any medical condition deemed exclusionary by the Principal Investigator\n* Current or past diagnosis of bipolar I\u002FII disorder, schizophrenia spectrum or other psychotic disorder; psychiatric hospitalization, suicidal ideation, suicide attempt, or self-harm behavior in the past 12 months\n* Initiation, discontinuation, or dose change of any psychotropic medication within the 3 months prior to screening\n* Allergy or sensitivity to any ingredient in the study product\n* History of drug or alcohol abuse in the past 12 months\n* Currently pregnant, breastfeeding, or planning to become pregnant during the study period\n* Participation in another interventional research study within 30 days prior to screening that could confound the outcomes of this study\n* Currently in prison, in custody, or otherwise a ward of the state",true,"FEMALE","25 Years","45 Years",{"count":126,"type":127},160,"ESTIMATED","INTERVENTIONAL",[130],"NA","This study looks at whether a daily probiotic supplement can help improve mild-to-moderate stomach and digestive symptoms, such as gas and bloating, in women who also experience symptoms commonly associated with hormonal fluctuations. Participants take either the probiotic or a placebo (a look-alike capsule with no active ingredients) once a day for 8 weeks, without knowing which one they are taking. Researchers will compare changes in digestive comfort, sleep, energy, and mood between the two groups over the study period. The study is conducted entirely online, so participants can take part from home.",[133,134],"Gastrointestinal Discomfort","Bloating",[136,137],"probiotics","bloating","2026-09-22",{"date":140,"type":141},"2026-09-25","ACTUAL",{"date":143,"type":141},"2026-09-19",{"date":145,"type":127},"2027-08-31",{"name":5,"class":6},1]