The Effectiveness and Tolerability of Multi-Strain Probiotics as Adjunctive Preventive Treatment of Episodic Migraine: A Single Centre, Randomised, Double- Blind, Sham-Controlled Phase 2 Trial (PROBIOTICS -EM).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change from baseline in mean monthly migraine days (MMD).
研究概览
简要总结
This study will assess the safety and efficacy of multi-strain probiotics as an adjunctive treatment for episodic migraine
详细描述
This is a phase 2 and single center, randomized, placebo-controlled double-blind clinical Trial. Episodic migraine patients according to International Headache Society criteria will be allocated randomly into two treatment arms. One group will receive active probiotics and another group will receive placebo for treatment phase. Both groups of patients will consume the treatment twice daily for 12 weeks and assessment will be made at baseline, baseline, week 4, 8 and 12
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)
盲法说明
The participants, care provider, investigator and outcome assessor of the study is blinded about the allocation status of the participants (Double blinded)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects fulfilling criteria for episodic migraine as per the Third Edition of The International Headache Society (ICHD-3) (Table 1)
- •Patients diagnosed with episodic migraine (4 or more episodes per month) for a minimum of 3 months.
- •On a steady treatment regimen: preventive and acute migraine medications and therapies unchanged over the last 3 months
- •Adult patients Age > 18 years old
- •A signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments.
排除标准
- •Lactose intolerance
- •Previous history of small and large bowel surgery
- •Use of probiotics or antibiotics in 2 weeks before baseline visit.
- •Patients with medical conditions such as severe hypertension, infections,
- •Malignancy, cardiovascular and cerebrovascular diseases, epilepsy, degenerative central nervous system diseases, renal failure, hepatic failure, bleeding diathesis and serious mental illnesses
- •Headache with red flags symptoms that may suggest organic secondary headaches.
- •Onset of headache more than 50 years
- •Prior GI infection in the previous 3-months
- •Morbid obesity (BMI >40)
- •Pregnant or lactating women
研究组 & 干预措施
Double-blind, placebo-controlled interventional study
Active treatment group will receive a 3-gram sachet of probiotics containing multi-strain of lactobacillus and Bifidobacterium 30 Colony Forming Unit x 109 to be taken twice daily for 12 weeks.
干预措施: (Microbial cell preparation) probiotics (Dietary Supplement)
Placebo
Patients will be given placebo sachet (exactly the same packaging as active comparator) to be taken 1 sachet twice daily for 12 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in mean monthly migraine days (MMD).
时间窗: Baseline, week 4, 8 and 12 post treatment
The MMD will be calculated using the MMD recorded by patients in a headache diary from each of the months of the double-blind treatment phase.
次要结局
- Change from baseline in mean Migraine Induced Disability Assessment Score (MIDAS)(Week 0 and 12 post treatment)
- Adverse events in response to probiotics(Week 4, 8 and 12 treatment)
- Reduction mean monthly migraine days(MMD)(12 weeks post treatment)
- Change from baseline in mean monthly pain intensity of migraine attacks(Baseline, week 4, 8 and 12 post treatment)
- Change from baseline in mean monthly migraine attacks(Baseline, week 4, 8 and 12 post treatment)
- Change from baseline in mean Depression, Anxiety and Stress Scale (DASS21)(Week 0 and 12 post treatment)
- Change from baseline in mean Migraine-Specific Quality-of-Life Questionnaire (MSQ V2) score(Week 0 and 12 post treatment)
- Serum Tumour Necrosis Factor Alpha (TNF-alpha)(Week 0 and 12 post treatment)
- Satisfaction measures of efficacy, tolerability, safety, and expectations of probiotics among the participants(Week 0 and 12 post treatment)
- Serum Highly sensitive C-Reactive Protein (hs-CRP)(Week 0 and 12 post treatment)
- Serum Interleukin 6 (IL- 6)(Week 0 and 12 post treatment)
研究者
Wan Aliaa Wan Sulaiman
Associate professor
Universiti Putra Malaysia