NCT04305522Unknown不适用
A Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Two Probiotic Interventions For The Prophylaxis of Migraine in Patients Diagnosed With Episodic Migraine
Biopolis S.L.4 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年3月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Number of days with migraine episodes
研究概览
简要总结
This study aims to understand the efficacy of two probiotic interventions as prophylaxes of migraine symptoms in individuals diagnosed with episodic migraine.
The primary outcome measure will be migraine days per month, but secondary outcome measures such as use of analgesia, the wider impact of migraine (as assessed through the HIT-6 score) will also be assessed. Finally adverse effects will be evaluated.
The study will have three arms: two arms including the two different probiotic preparations and a third placebo arm.
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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 - 65 years.
- •Signature of informed consent by the patient.
- •Patients with confirmed migraine, diagnosed by a neurologist
- •Patient-indicated frequency of migraine attacks (or days) of at least 4 per month.
- •Fairly predictable and stable pattern of migraine attacks (frequency, duration, intensity)
排除标准
- •Patients diagnosed with chronic migraine
- •Migraine patients suffering from medication-dependent headaches.
- •Patients suffering from cluster or tension-related headaches.
- •Patients who used antibiotics up to two weeks before the start of the study.
- •Patients who have taken other probiotics in the previous two months.
- •Patients with chronic use of non-steroidal anti-inflammatory drugs.
- •Patients with inflammatory bowel disease (due to increased intestinal permeability).
- •Patients who are pregnant, breastfeeding or who do not commit to using an effective method of contraception during the course of the study.
结局指标
主要结局
Number of days with migraine episodes
时间窗: 12-week
Number of days with migraine episodes, in weeks 12.
次要结局
- Number of migraine episodes(12 weeks)
- Treatment adherence rate(12 weeks)
- Number of adverse events(12 weeks)
- Adherence to the treatment.(12 weeks)
- Number of days that each patient requires the administration analgesia(12 weeks)
- Headache Impact Test (HIT-6) score(12 weeks)
研究者
研究点 (4)
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