The Effects of Probiotics on the Frequency and Intensity of Migraine Attacks and Intestinal Permeability. A Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Frequency of migraine attacks
研究概览
简要总结
RATIONALE: The prevalence of migraine is higher in patients with various intestinal diseases. An explanation could be that migraine is caused by a 'leaky gut': an increased intestinal permeability that allows food particles to pass the gastrointestinal wall. Probiotics may be able to improve intestinal barrier function.
OBJECTIVE: To test whether probiotics, as adjuvant therapy, can reduce incidence and severity of migraine attacks by reducing intestinal permeability.
STUDY DESIGN: 12-week placebo-controlled randomized double-blind intervention with selected probiotics.
STUDY POPULATION: Adults who experience at least 4 migraine attacks per month. INTERVENTION: Subjects will receive either one daily dose of 2 g of Ecologic® Barrier or 2 grams of the placebo, containing only the carrier material (both provided by Winclove Probiotics).
MAIN STUDY PARAMETERS/ENDPOINTS: Incidence and severity of migraine attacks, measured by diaries and validated headache questionnaires will be measured at baseline and after 4, 8, and 12 weeks of probiotic/placebo administration. Secondary, intestinal permeability will be measured by the lactulose/mannitol absorption test in urine (screening, baseline and 12 weeks) and by fecal zonulin (baseline, 4, 8, and 12 weeks). Inflammation will be assessed from blood C-reactive protein and cytokine concentrations (baseline, 4, 8, and 12 weeks). Fecal samples will also be used for microbial analysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects confirm to have migraine characterized by :
- •Recurrent attacks of moderate to severe headaches, often one-sided and pounding, often with nausea and/or vomiting, aggravated by physical activity
- •Sensitivity for light or sounds is possible but not exclusive.
- •Attacks last for 4 to 72 hours.
- •Self-reported frequency of migraine attacks (or days) at least 4 per month
- •Fairly predictable/stable pattern of migraine attacks (frequency, duration, intensity)
- •Age ≥ 18 years
- •Good overall health (self-reported in medical questionnaire)
排除标准
- •Migraine patients who suffer from chronic daily migraine/headaches
- •Migraine patients who suffer from medication-dependent headaches
- •Subjects who suffer from cluster headache or tension-type headaches
- •Subjects who used antibiotics up to two months before the start of the study
- •Subjects who are unwilling to stop taking probiotics other than study products
- •Patients with a chronic use of non steroid anti inflammatory drugs (because of increased gut permeability)
- •Patients with inflammatory bowel diseases (because of increased gut permeability)
- •Pregnancy or lactation (because of their possible effect on migraine incidence)
结局指标
主要结局
Frequency of migraine attacks
时间窗: 12 weeks
次要结局
- Inflammation markers.(12 weeks)
- Intestinal permeability(12 weeks)