Effect of Probiotics on Quality of Life, Activities of Daily Living and Anxiety in Post Stroke Patients

Effect of Probiotics on Quality of Life, Activities of Daily Living and Anxiety in Post Stroke Patients

Research on Effect of probiotics on quality of life, activities of daily living and anxiety in post stroke patients

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.

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