Status:
UNKNOWN
Probiotics for the Prophylaxis of Migraine
Lead Sponsor:
Biopolis S.L.
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 migr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 2 2021
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04305522
Start Date
March 2 2020
End Date
May 2 2021
Last Update
March 12 2020
Active Locations (2)
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1
Hospital Universitario del Vinalopó
Elche, Alicante, Spain, 03293
2
Hospital Universitario de Torrevieja
Torrevieja, Alicante, Spain, 03186