Migraine
Conditions
Keywords
Probiotic, Migraine
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.
Interventions
DIETARY_SUPPLEMENTProbiotic 1
Probiotic mixture with maltodextrin as a carrier.
DIETARY_SUPPLEMENTPlacebo
Placebo comparator with maltodextrin as a carrier.
DIETARY_SUPPLEMENTProbiotic 2
Probiotic mixture with maltodextrin as a carrier.
Sponsors
Biopolis S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 - 65 years. 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
1. Patients diagnosed with chronic migraine 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days with migraine episodes | 4-week | Number of days with migraine episodes in weeks 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days that each patient requires the administration analgesia | 4 weeks | Number of days that each patient requires the administration analgesia, in weeks 4 |
| Headache Impact Test (HIT-6) score | 4 weeks | 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) |
| Number of migraine episodes | 4 weeks | Number of migraine episodes, in weeks 4 |
| Number of adverse events | 12 weeks | Numbre od adverse effects reported |
| Adherence to the treatment. | 12 weeks | Percentage of treatment intake days. |
| Treatment adherence rate | 12 weeks | Treatment adherence rate using the returned capsules. |
Countries
Spain
Contacts
Primary ContactMaría Empar Chenoll, PhD
Outcome results
None listed