Effect of Probiotics on Quality of Life, Activities of Daily Living and Anxiety in Post Stroke Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hexbio, Placebo.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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. - Other Placebo
Matching placebo sachets, identical in appearance and schedule
Primary outcome measures
- Primary Objective [Time frame: 3 months]
Secondary outcome measures (3)
- Secondary objectives: Activities of daily living [Time frame: 3 months]
- Secondary objective: Anxiety Score [Time frame: 3 months]
- Secondary objective: modified Rankin scale [Time frame: 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Malaysia · 1 center
- National University of Malaysia — Kuala Lumpur
Identifiers
NCT: NCT07207941 · JEP-2025-671