Stroke
Conditions
Keywords
stroke, probiotic, quality of life, anxiety, activities of daily living
Brief summary
Research on Effect of probiotics on quality of life, activities of daily living and anxiety in post stroke patients
Detailed description
Background: Stroke 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. Objective: To evaluate the effects of probiotic supplementation compared to placebo on QoL, ADL, anxiety symptoms, and functional outcomes in post-stroke patients. Study Design: This is a single-center, randomized, double-blind, placebo-controlled clinical trial. Methods: A 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: * Intervention: HEXBIO MCP Granule probiotics (Lactobacillus acidophilus, L. casei, L. lactis, Bifidobacterium bifidum, B. infantis, B. longum), one sachet twice daily for 3 months. * 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. Sample Size: A total of 110 patients (55 per arm) will provide sufficient power to detect clinically meaningful differences, accounting for a 5% dropout rate. Data Analysis: Intention-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 \< 0.05. Study Duration: Recruitment will begin in Sept 2025 and is expected to complete by May 2028. Expected Impact: This 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.
Interventions
DIETARY_SUPPLEMENTHexbio
HEXBIO MCP Granule probiotics (Lactobacillus acidophilus, L. casei, L. lactis, Bifidobacterium bifidum, B. infantis, B. longum), one sachet twice daily for 3 months.
OTHERPlacebo
Matching placebo sachets, identical in appearance and schedule
Sponsors
B-Crobes Laboratory Sdn. Bhd
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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) * Pregnancy and breastfeeding. * Secondary cause of stroke- vasculitis, cerebral venous sinus thrombosis, connective tissue disorders * Past history of psychiatric disorders (depression, anxiety) * Recent use of probiotics and allergies to probiotics * Immunosuppressed patients (HIV, malignancy) * Patient with septicemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary objective: Anxiety Score | 3 months | 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 | 3 months | 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. |
| Secondary objectives: Activities of daily living | 3 months | 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. |
Countries
Malaysia
Contacts
Primary ContactHui Jan Tan, MD FRCP MMed
Outcome results
None listed