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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic 1 group | Experimental | A commercially-available multi-strain probiotic with added magnesium and vitamin B6 |
|
| Probiotic 2 group | Experimental | A multi-strain probiotic |
|
| Placebo group | Placebo Comparator | Identical placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic 1 | Dietary Supplement | Probiotic mixture with maltodextrin as a carrier. |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| María Empar Chenoll, PhD | Contact | +34 673 53 53 44 | maria.chenoll@adm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario del Vinalopó | Elche | Alicante | 03293 | Spain |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Double-blind
| Placebo |
| Dietary Supplement |
Placebo comparator with maltodextrin as a carrier. |
|
| Probiotic 2 | Dietary Supplement | Probiotic mixture with maltodextrin as a carrier. |
|
| 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 |
| Hospital Universitario de Torrevieja | Torrevieja | Alicante | 03186 | Spain |
|
| D009422 | Nervous System Diseases |