Effect of Probiotics on Quality of Life, Activities of Daily Living and Anxiety in Post Stroke Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Hexbio, Placebo.
- Кому может быть актуально
- Состояния в реестре: Stroke. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Малайзия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Research on Effect of probiotics on quality of life, activities of daily living and anxiety in post stroke patients
Подробное описание
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.
Вмешательства
- Пищевая добавка Hexbio
HEXBIO MCP Granule probiotics (Lactobacillus acidophilus, L. casei, L. lactis, Bifidobacterium bifidum, B. infantis, B. longum), one sachet twice daily for 3 months. - Другое Placebo
Matching placebo sachets, identical in appearance and schedule
Первичные конечные точки
- Primary Objective [Срок оценки: 3 months]
Вторичные конечные точки (3)
- Secondary objectives: Activities of daily living [Срок оценки: 3 months]
- Secondary objective: Anxiety Score [Срок оценки: 3 months]
- Secondary objective: modified Rankin scale [Срок оценки: 3 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Малайзия · 1 центр
- National University of Malaysia — Kuala Lumpur
Идентификаторы
NCT: NCT07207941 · JEP-2025-671