Research on Effect of probiotics on quality of life, activities of daily living and anxiety in post stroke patients
Patients diagnosed with moderate ischemic stroke with mRS score of 2-4 from onset of stroke up to 3 months.
Patients aged 18 to 80 years, who are able to read and write in English and/or Bahasa Malaysia
Provide informed consent
Patients with aphasia
Patients who have received thrombolysis or mechanical thrombectomy
Gastrointestinal related diseases such as lactose intolerance, coeliac disease, Renal or hepatic insufficiency (Based on recent six-month blood profile)
Progressive neurological disease (Alzheimer's disease, Parkinson's Disease, Motor Neuron Disease)
Parallel
Hexbio
Dietary supplementHEXBIO MCP Granule probiotics (Lactobacillus acidophilus, L. casei, L. lactis, Bifidobacterium bifidum, B. infantis, B. longum), one sachet twice daily for 3 months.
Placebo
Other interventionMatching placebo sachets, identical in appearance and schedule
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/productivity. 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.
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.
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.
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.
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National University of Malaysia
Lead sponsor
B-Crobes Laboratory Sdn. Bhd
Collaborator
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