Effect of synbiotic supplementation on migraine characteristics and inflammatory biomarkers in women with migraine: Results of a randomized controlled trial.

Literature suggests a relationship between gut microbiome and migraine headache pathogenesis. However, the effect of manipulating gut microbiome on migraine remains unclear. This study aimed to investigate the effect of synbiotics on migraine characteristics and inflammatory markers in women with migraines. Sixty-nine participants completed a randomized double-blind controlled trial, receiving synbiotic (109 CFU of 12 types of probiotics + fructooligosaccharides prebiotic) or placebo supplementation, twice per day for 12 weeks. Migraine severity, migraine days per month, frequency and duration of attacks, number of painkillers consumed, gastrointestinal problems, serum High sensitive C-Reactive Protein (Hs-CRP) (a marker of inflammation) and zonulin (a marker of gut permeability) levels were measured at baseline and the end of the intervention. Bivariate comparison and intention-to-treat (ITT) were used for analysis. Synbiotic supplementation compare to the placebo resulted in a significant reduction in the mean frequency of migraine attacks (-1.02 vs -0.30, respectively, P = 0.011), percentage change of the number of painkillers used (-7.5% vs 27.5%, respectively, P = 0.008) and gastrointestinal problems (-35% vs -2.5%, respectively, P = 0.005), zonulin level (-4.12 vs 0.85 ng/ml, respectively, P = 0.034), and Hs-CRP level (-0.43 vs -0.09 mg/l, respectively, P = 0.022). Reduction in the migraine severity and duration did not reach a statistically significant level. Synbiotic supplementation may be considered as a complementary treatment for women with migraines to improve migraine characteristics and markers of inflammation and gut permeability and reduce the burden of disease.