Migraine Clinical Trial
Official title:
The Effects of Probiotics on the Frequency and Intensity of Migraine Attacks and Intestinal Permeability. A Placebo-controlled Trial
RATIONALE: The prevalence of migraine is higher in patients with various intestinal
diseases. An explanation could be that migraine is caused by a 'leaky gut': an increased
intestinal permeability that allows food particles to pass the gastrointestinal wall.
Probiotics may be able to improve intestinal barrier function.
OBJECTIVE: To test whether probiotics, as adjuvant therapy, can reduce incidence and
severity of migraine attacks by reducing intestinal permeability.
STUDY DESIGN: 12-week placebo-controlled randomized double-blind intervention with selected
probiotics.
STUDY POPULATION: Adults who experience at least 4 migraine attacks per month. INTERVENTION:
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).
MAIN STUDY PARAMETERS/ENDPOINTS: Incidence and 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. Secondary, 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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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