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

N/ANot Yet RecruitingNCT07207941

National University of Malaysia110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

110

Conditions

Stroke

Interventions

HexbioDIETARY_SUPPLEMENT

HEXBIO MCP Granule probiotics (Lactobacillus acidophilus, L. casei, L. lactis, Bifidobacterium bifidum, B. infantis, B. longum), one sachet twice daily for 3 months.

PlaceboOTHER

Matching placebo sachets, identical in appearance and schedule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

National University of Malaysia

Kuala Lumpur, Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 3 months

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.

Time frame: 3 months

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.

Time frame: 3 months

Central Contacts

Hui Jan Tan, MD FRCP MMed

CONTACT

+60391455555 tanhuijan@ukm.edu.my

Data from ClinicalTrials.gov

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