NCT04305522UnknownNot Applicable
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
Biopolis S.L.4 sites in 1 country75 target enrollmentStarted: March 2, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 75
- Locations
- 4
- Primary Endpoint
- Number of days with migraine episodes
Study Overview
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 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Double-blind
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Number of days with migraine episodes
Time Frame: 12-week
Number of days with migraine episodes, in weeks 12.
Secondary Outcomes
- Number of migraine episodes(12 weeks)
- Treatment adherence rate(12 weeks)
- Number of adverse events(12 weeks)
- Adherence to the treatment.(12 weeks)
- Number of days that each patient requires the administration analgesia(12 weeks)
- Headache Impact Test (HIT-6) score(12 weeks)
Investigators
Study Sites (4)
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