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

NCT ID: NCT07207941

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-05-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

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.

Group Type: ACTIVE_COMPARATOR

Hexbio

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching placebo sachets, identical in appearance and schedule

Interventions

Hexbio

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Matching placebo sachets, identical in appearance and schedule

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B-Crobes Laboratory Sdn. Bhd

UNKNOWN

Sponsor Role: collaborator

National University of Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Tan Hui Jan

Consultant Neurologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nasir Shafiee

Role: STUDY_DIRECTOR

National University of Malaysia

Locations

National University of Malaysia

Kuala Lumpur, Kuala Lumpur, Malaysia

Countries

Malaysia

Central Contacts

Hui Jan Tan, MD FRCP MMed

Role: CONTACT

tanhuijan@ukm.edu.my

+60391455555 ext. 5583

Facility Contacts

Hui Jan Tan, MD FRCP MMed

Role: primary

tanhuijan@ukm.edu.my

0391455555 ext. 5583

Nasir Shafiee, Masters in Obs and Gyne

Role: backup

sepukm@ukm.edu.my

0391455555

Other Identifiers

JEP-2025-671

Identifier Type: -

Identifier Source: org_study_id