Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2020-03-02
2021-05-02
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Probiotic 1 group
A commercially-available multi-strain probiotic with added magnesium and vitamin B6
Probiotic 1
Probiotic mixture with maltodextrin as a carrier.
Probiotic 2 group
A multi-strain probiotic
Probiotic 2
Probiotic mixture with maltodextrin as a carrier.
Placebo group
Identical placebo
Placebo
Placebo comparator with maltodextrin as a carrier.
Interventions
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Probiotic 1
Probiotic mixture with maltodextrin as a carrier.
Placebo
Placebo comparator with maltodextrin as a carrier.
Probiotic 2
Probiotic mixture with maltodextrin as a carrier.
Eligibility Criteria
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Inclusion Criteria
2. Signature of informed consent by the patient.
3. Patients with confirmed migraine, diagnosed by a neurologist
4. Patient-indicated frequency of migraine attacks (or days) of at least 4 per month.
5. Fairly predictable and stable pattern of migraine attacks (frequency, duration, intensity)
Exclusion Criteria
2. Migraine patients suffering from medication-dependent headaches.
3. Patients suffering from cluster or tension-related headaches.
4. Patients who used antibiotics up to two weeks before the start of the study.
5. Patients who have taken other probiotics in the previous two months.
6. Patients with chronic use of non-steroidal anti-inflammatory drugs.
7. Patients with inflammatory bowel disease (due to increased intestinal permeability).
8. Patients who are pregnant, breastfeeding or who do not commit to using an effective method of contraception during the course of the study.
18 Years
65 Years
ALL
No
Sponsors
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Biopolis S.L.
INDUSTRY
Responsible Party
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Locations
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Hospital Universitario del Vinalopó
Elche, Alicante, Spain
Hospital Universitario de Torrevieja
Torrevieja, Alicante, Spain
Countries
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Central Contacts
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Facility Contacts
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Ana López García
Role: primary
Erika Maria Torres San Narciso
Role: primary
Other Identifiers
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MIGR_PRO.2
Identifier Type: -
Identifier Source: org_study_id
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