Probiotics as a Promising Adjunct: Improving Fatigue, Quality of Life, Disability, Mood and Inflammatory Markers in Egyptian Relapsing-Remitting Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of patients with improving in fatigue
研究概览
简要总结
This study aimed to assess the effect of probiotic supplementation on fatigue, quality of life, disability, depression and inflammatory markers in patients with relapsing-remitting multiple sclerosis (RRMS).
Patients were randomized to receive probiotics plus standard therapy The study sought to determine whether modulation of gut microbiota could provide additional clinical and immunological benefits in RRMS management.
详细描述
This trial was conducted as part of a Doctoral (PhD) thesis at the Department of Neurology, Cairo University
The purpose of the trial was to evaluate the potential effects of probiotic supplementation on clinical and biological outcomes in patients with relapsing-remitting multiple sclerosis (RRMS).
Multiple sclerosis is a chronic inflammatory and demyelinating disease of the central nervous system, in which immune dysregulation and gut microbiota imbalance may play a key role.
Recent evidence suggests that probiotics could exert beneficial immunomodulatory and anti-inflammatory effects, potentially improving patient outcomes.
In this randomized controlled study, patients with RRMS received either probiotic supplementation or standard therapy alone for a defined period.
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
- None (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically definite MS patients with a diagnosis of relapsing remitting multiple sclerosis according to revised McDonald criteria
- •EDSS score of ≤ 4
排除标准
- •Progressive MS either; primary progressive MS or secondary progressive MS
- •Patients who had relapses and glucocorticoid therapy within the past 30 days.
- •Pregnancy and women who were lactating within the prior six month
- •Patients taking antibiotics
- •History of gastroenteritis and bowel surgery over the past month, inflammatory bowel disease
- •Presence of diabetes (type I & type II) or diseases causing significant nutritional status impairment (malignancy, chronic infections)
- •Patients who have changed their disease modifying drugs in the past 6 months prior to study
- •Impaired cognition that limited ability to complete the questionnaires. Addiction to drugs or alcohol.
研究组 & 干预措施
Controlled group
standard treatment only
干预措施: Standard medical treatment (Other)
Probiotic Group
probiotic dietary supplements
干预措施: Probiotic dietary supplement (Dietary Supplement)
结局指标
主要结局
Number of patients with improving in fatigue
时间窗: 3 months
changes in fatigue status using modified fatigue impact scale which range from 0 to 84 where high scores worse outcome
次要结局
- Inflammatory biomarkers(3 months)
研究者
Foraysa Mohammed Talaat
Faculty of medicine, Cairo university
Cairo University