Effects of a Multispecies Probiotic on Migraine: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Reduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score
研究概览
简要总结
The prevalence of migraine is higher in female patients with various intestinal diseases. An explanation could be that migraine is caused by a leaky gut, defined by increased intestinal permeability that permits particles to pass through the gastrointestinal wall. Probiotics, may be able to improve intestinal barrier function.
OBJECTIVE: To test whether probiotics, as adjucnt therapy, can reduce incidence and severity of migraine attacks by reducing intestinal permeability.
详细描述
Given the significant unmet need for improved therapies that address migraine disorders and concurrent irritable bowel syndrome (IBS), this study seeks to investigate the impact of probiotics on the sequelae of symptoms associated with both migraine and IBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Episodic migraine diagnosis for a minimum of 1 year (12-months)
- •Between 3-12 migraine episodes /month
- •Comorbid, symptomatic, irritable bowel syndrome during the screening period
- •On a steady treatment regimen: preventative and acute migraine medications and therapies unchanged over the last 6 months
- •Access to Scripps Center for Integrative Medicine
- •Access to smartphone or computer to complete electronic surveys
排除标准
- •Other GI or hepatic diagnoses (Inflammatory Bowel Disease (IBD), Small Intestinal Bacterial Overgrowth (SIBO), Non-Alcoholic Fatty Liver Disease (NAFLD), elevated Liver Function Tests (LFTs) within the last 6 months)
- •Prior GI surgery
- •Prior GI infection in the previous 3-months
- •Antibiotic treatment in previous last 3 months
- •Diagnosed Autoimmune disease
- •Current corticosteroids use
- •Morbid obesity (BMI >40)
- •Took Probiotics or Probiotic-containing supplements or therapy in the previous 3-months
- •Diagnosis of post-traumatic headache or cervicogenic headache
- •Pregnancy or plans to become pregnant during study participation
结局指标
主要结局
Reduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score
时间窗: Change day 0 to week 12
This survey measures headache frequency, disability, severity
次要结局
- Reduced severity of Gastrointestinal (GI) symptoms (per Irritable Bowel Syndrome Severity Scoring System (IBS -SSS))(Change day 0 to week 12)
- Reduced generalized anxiety (per Generalized Anxiety Disorder (GAD-7))(Change day 0 to week 12)
- Improved Quality of Life (QoL) and reduced depressive symptoms (per Patient Health Questionnaire (PHQ-9))(Change day 0 to week 12)
- Change in acute medication requirements(Change day 0 to week 12)
- Reduce headache parameters (headache episodes, headache days, intensity, duration) based on MIDAS subcomponents and journal/diary(Change day 0 to week 12)