[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608929":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":33,"studyPopulation":23,"armGroups":34,"interventions":47,"overallOfficials":56,"centralContacts":60,"locations":67,"responsibleParty":87,"collaborators":90,"id":94,"slug":23,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":23,"eligibilityCriteria":98,"healthyVolunteers":95,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":23,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":117,"whyStopped":23,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"National University of Malaysia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Primary Objective","QoL measured using the Stroke-Specific Quality of Life (SS-QoL) scale. To assess the patient's quality of life, validated Stroke Specific Quality of life (SS-QoL) questionnaire in English version will be used. This questionnaire consists of 12 domains which includes energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, and work\u002Fproductivity. Each question is scored using 5 point Likert scale and the total score is calculated which can range from 49-245. The higher the score, better the quality of life. This questionnaire is validated and requested for permission.","3 months",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Secondary objectives: Activities of daily living","Activities of daily living is measured using Barthel Index (BI) which contains of 10 items. BI is a measurement scale used to assess an individual's ability to perform activities of daily living (ADL) and mobility. The score ranges from 0-10 and the overall score is calculated. The higher the score, better the functional status.",{"measure":18,"description":19,"timeFrame":12},"Secondary objective: Anxiety Score","Anxiety score is calculated using Generalised Anxiety Disorder- 7 (GAD-7) score. GAD 7 is a screening tool and it has 7 items with score ranging from 0-3 for each item and the total score is calculated. The higher the score, the worse the anxiety symptoms. A score of 10 indicates anxiety.",{"measure":21,"description":22,"timeFrame":12},"Secondary objective: modified Rankin scale","Modified Rankin Scale (mRS) assess functional recovery and independence after stroke. It uses a 5 point scale, where a higher scale indicates more severe disability.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":30},"DOUBLE",[31,32],"PARTICIPANT","INVESTIGATOR","Background:\n\nStroke survivors often experience reduced quality of life (QoL), impaired activities of daily living (ADL), and high levels of anxiety. Emerging evidence suggests that modulation of the gut-brain axis through probiotics may improve neuropsychological and functional outcomes. However, data from Malaysian populations are lacking.\n\nObjective:\n\nTo evaluate the effects of probiotic supplementation compared to placebo on QoL, ADL, anxiety symptoms, and functional outcomes in post-stroke patients.\n\nStudy Design:\n\nThis is a single-center, randomized, double-blind, placebo-controlled clinical trial.\n\nMethods:\n\nA total of 110 patients with moderate ischemic stroke (mRS 2-4) within 3 months of onset will be recruited from the Neurology Clinic, Hospital Canselor Tuanku Muhriz, Kuala Lumpur. Participants will be randomized (1:1) to receive either:\n\n* Intervention: HEXBIO MCP Granule probiotics (Lactobacillus acidophilus, L. casei, L. lactis, Bifidobacterium bifidum, B. infantis, B. longum), one sachet twice daily for 3 months.\n* Control: Matching placebo sachets, identical in appearance and schedule. Both groups will continue standard stroke treatment. Primary outcome is QoL measured using the Stroke-Specific Quality of Life (SS-QoL) scale. Secondary outcomes include ADL (Barthel Index), anxiety symptoms (GAD-7), and functional status (mRS score). Assessments will be performed at baseline and 3 months.\n\nSample Size:\n\nA total of 110 patients (55 per arm) will provide sufficient power to detect clinically meaningful differences, accounting for a 5% dropout rate.\n\nData Analysis:\n\nIntention-to-treat analysis will be conducted using SPSS v26. Between-group differences will be assessed using appropriate parametric or non-parametric tests, with significance set at p \\\u003C 0.05.\n\nStudy Duration:\n\nRecruitment will begin in Sept 2025 and is expected to complete by May 2028.\n\nExpected Impact:\n\nThis study will provide new evidence on the role of probiotics in improving QoL, daily functioning, and psychological well-being among Malaysian post-stroke patients, potentially informing adjunctive rehabilitation strategies.",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"Intervention","ACTIVE_COMPARATOR","Intervention group HEXBIO MCP Granule probiotics (Lactobacillus acidophilus, L. casei, L. lactis, Bifidobacterium bifidum, B. infantis, B. longum), one sachet twice daily for 3 months.",[40],"Dietary Supplement: Hexbio",{"label":42,"type":43,"description":44,"interventionNames":45},"Placebo","PLACEBO_COMPARATOR","Placebo Control Matching placebo sachets, identical in appearance and schedule.",[46],"Other: Placebo",[48,53],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":23},"DIETARY_SUPPLEMENT","Hexbio","HEXBIO MCP Granule probiotics (Lactobacillus acidophilus, L. casei, L. lactis, Bifidobacterium bifidum, B. infantis, B. longum), one sachet twice daily for 3 months.",[36],{"type":6,"name":42,"description":54,"armGroupLabels":55,"otherNames":23},"Matching placebo sachets, identical in appearance and schedule",[42],[57],{"name":58,"affiliation":5,"role":59},"Nasir Shafiee","STUDY_DIRECTOR",[61],{"name":62,"role":63,"phone":64,"phoneExt":65,"email":66},"Hui Jan Tan, MD FRCP MMed","CONTACT","+60391455555","5583","tanhuijan@ukm.edu.my",[68],{"facility":5,"status":23,"city":69,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Kuala Lumpur","56000","Malaysia","MY",{"type":74,"coordinates":75},"Point",[76,77],101.68653,3.1412,{"lat":77,"lon":76},[80,82,85],{"name":62,"role":63,"phone":81,"phoneExt":65,"email":66},"0391455555",{"name":83,"role":63,"phone":81,"phoneExt":23,"email":84},"Nasir Shafiee, Masters in Obs and Gyne","sepukm@ukm.edu.my",{"name":62,"role":86,"phone":23,"phoneExt":23,"email":23},"PRINCIPAL_INVESTIGATOR",{"type":86,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Tan Hui Jan","Consultant Neurologist",[91],{"name":92,"class":93},"B-Crobes Laboratory Sdn. Bhd","UNKNOWN","100608929",false,"NCT07207941","Effect of Probiotics on Quality of Life, Activities of Daily Living and Anxiety in Post Stroke Patients","Inclusion Criteria:\n\n* Patients diagnosed with moderate ischemic stroke with mRS score of 2-4 from onset of stroke up to 3 months.\n* Patients aged 18 to 80 years, who are able to read and write in English and\u002For Bahasa Malaysia\n* Provide informed consent\n\nExclusion Criteria:\n\n* Patients with aphasia\n* Patients who have received thrombolysis or mechanical thrombectomy\n* Gastrointestinal related diseases such as lactose intolerance, coeliac disease, Renal or hepatic insufficiency (Based on recent six-month blood profile)\n* Progressive neurological disease (Alzheimer's disease, Parkinson's Disease, Motor Neuron Disease)\n* Pregnancy and breastfeeding.\n* Secondary cause of stroke- vasculitis, cerebral venous sinus thrombosis, connective tissue disorders\n* Past history of psychiatric disorders (depression, anxiety)\n* Recent use of probiotics and allergies to probiotics\n* Immunosuppressed patients (HIV, malignancy)\n* Patient with septicemia","ALL","18 Years","80 Years",{"count":103,"type":104},110,"ESTIMATED","INTERVENTIONAL",[107],"NA","Research on Effect of probiotics on quality of life, activities of daily living and anxiety in post stroke patients",[110],"Stroke",[112,113,114,115,116],"stroke","probiotic","quality of life","anxiety","activities of daily living","NOT_YET_RECRUITING","2025-09-26",{"date":120,"type":121},"2025-10-06","ACTUAL",{"date":123,"type":104},"2025-09-30",{"date":125,"type":104},"2028-05-31",{"name":5,"class":6},1]