Probiotics for the Prophylaxis of Migraine

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Migraine

Intervention / Treatment
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* Dietary Supplement: Probiotic 1
* Dietary Supplement: Placebo
* Dietary Supplement: Probiotic 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic 1 group<br>A commercially-available multi-strain probiotic with added magnesium and vitamin B6 | Dietary Supplement: Probiotic 1<br>* Probiotic mixture with maltodextrin as a carrier.<br>|
| Experimental: Probiotic 2 group<br>A multi-strain probiotic | Dietary Supplement: Probiotic 2<br>* Probiotic mixture with maltodextrin as a carrier.<br>|
| Placebo Comparator: Placebo group<br>Identical placebo | Dietary Supplement: Placebo<br>* Placebo comparator with maltodextrin as a carrier.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days with migraine episodes | Number of days with migraine episodes in weeks 4 | 4-week | 
| Number of days with migraine episodes | Number of days with migraine episodes, in weeks 8 | 8-week | 
| Number of days with migraine episodes | Number of days with migraine episodes, in weeks 12. | 12-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of migraine episodes | Number of migraine episodes, in weeks 4 | 4 weeks | 
| Number of migraine episodes | Number of migraine episodes, in weeks 8 | 8 weeks | 
| Number of migraine episodes | Number of migraine episodes, in weeks 12. | 12 weeks | 
| Number of days that each patient requires the administration analgesia | Number of days that each patient requires the administration analgesia, in weeks 4 | 4 weeks | 
| Number of days that each patient requires the administration analgesia | Number of days that each patient requires the administration analgesia, in weeks 8 | 8 weeks | 
| Number of days that each patient requires the administration analgesia | Number of days that each patient requires the administration analgesia, in weeks 12 | 12 weeks | 
| Headache Impact Test (HIT-6) score | Headache Impact Test (HIT-6) score at weeks 0 and 4 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78) | 4 weeks | 
| Headache Impact Test (HIT-6) score | Headache Impact Test (HIT-6) score at weeks 8 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78) | 8 weeks | 
| Headache Impact Test (HIT-6) score | Headache Impact Test (HIT-6) score at weeks 12 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78) | 12 weeks | 
| Treatment adherence rate | Treatment adherence rate using the returned capsules. | 12 weeks | 
| Number of adverse events | Numbre od adverse effects reported | 12 weeks | 
| Adherence to the treatment. | Percentage of treatment intake days. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic, Migraine