migraine unilateral headache
Conditions
Interventions
Subjects will receive either one daily dose of 2 g of Ecologic® Barrier or 2
grams of the placebo, containing only the carrier material (both provided by
Winclove Probiotics).
Sponsors
Wageningen Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects confirm to have migraine characterized by : o Recurrent attacks of moderate to severe headaches, often one-sided and pounding, often with nausea and/or vomiting, aggravated by physical activity o Sensitivity for light or sounds is possible but not exclusive. o Attacks last for 4 to 72 hours. - Self-reported frequency of migraine attacks (or days) at least 4 per month - Fairly predictable/stable pattern of migraine attacks (frequency, duration, intensity) - Age >= 18 years - General good health
Exclusion criteria
Exclusion criteria: - Migraine patients who suffer from chronic daily migraine/headaches - Migraine patients who suffer from medication-dependent headaches - Subjects who suffer from cluster headache or tension-type headaches - Subjects who used antibiotics up to two months before the start of the study - Pregnancy or lactation (because of their possible effect on migraine incidence - Patients who are unwilling to stop current use of probiotics - Patients who have a chronic use of NSAIDs - patients with inflammatory bowel diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of migraine (measured by diaries, number of days with migraine in 4 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of migraine attacks, measured by diaries and validated headache questionnaires will be measured at baseline and after 4, 8, and 12 weeks of probiotic/placebo administration. Further, intestinal permeability will be measured by the lactulose/mannitol absorption test in urine (screening, baseline and 12 weeks) and by fecal zonulin (baseline, 4, 8, and 12 weeks). Inflammation will be assessed from blood C-reactive protein and cytokine concentrations (baseline, 4, 8, and 12 weeks). Fecal samples will also be used for microbial analysis. | — |
Countries
Netherlands
Outcome results
None listed