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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
Probiotic mixture with maltodextrin as a carrier.
Placebo comparator with maltodextrin as a carrier.
Probiotic mixture with maltodextrin as a carrier.
Hospital Universitario del Vinalopó
Elche, Alicante, Spain
Hospital Universitario de Torrevieja
Torrevieja, Alicante, Spain
Number of days with migraine episodes
Number of days with migraine episodes in weeks 4
Time frame: 4-week
Number of days with migraine episodes
Number of days with migraine episodes, in weeks 8
Time frame: 8-week
Number of days with migraine episodes
Number of days with migraine episodes, in weeks 12.
Time frame: 12-week
Number of migraine episodes
Number of migraine episodes, in weeks 4
Time frame: 4 weeks
Number of migraine episodes
Number of migraine episodes, in weeks 8
Time frame: 8 weeks
Number of migraine episodes
Number of migraine episodes, in weeks 12.
Time frame: 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
Time frame: 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
Time frame: 8 weeks
Number of days that each patient requires the administration analgesia
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Number of days that each patient requires the administration analgesia, in weeks 12
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 12 weeks
Treatment adherence rate
Treatment adherence rate using the returned capsules.
Time frame: 12 weeks
Number of adverse events
Numbre od adverse effects reported
Time frame: 12 weeks
Adherence to the treatment.
Percentage of treatment intake days.
Time frame: 12 weeks