Effect of Probiotics on Quality of Life, Activities of Daily Living and Anxiety in Post Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Primary Objective
研究概览
简要总结
Research on Effect of probiotics on quality of life, activities of daily living and anxiety in post stroke patients
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo Control Matching placebo sachets, identical in appearance and schedule.
干预措施: Placebo (Other)
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.
干预措施: Hexbio (Dietary Supplement)
结局指标
主要结局
Primary Objective
时间窗: 3 months
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.
次要结局
- Secondary objective: modified Rankin scale(3 months)
- Secondary objectives: Activities of daily living(3 months)
- Secondary objective: Anxiety Score(3 months)
研究者
Tan Hui Jan
Consultant Neurologist
National University of Malaysia