NCT07207941

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: National University of Malaysia · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-30
• Primary completion: 2025-09-30
• Completion: 2028-05-31
• First posted: 2025-10-06
• Last updated: 2025-10-06

Locations

1 site across 1 country: Malaysia