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

National University of Malaysia

Status: Not yet enrolling

Conditions: Stroke

Treatments: Other: Placebo; Dietary Supplement: Hexbio

Study type: Interventional

Funder types: Other

Identifiers

NCT07207941

JEP-2025-671

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Hexbio

Placebo

Placebo Comparator group

Description:

Placebo Control Matching placebo sachets, identical in appearance and schedule.

Treatment:

Other: Placebo