The prevalence of migraine is higher in female patients with various intestinal diseases. An explanation could be that migraine is caused by a leaky gut, defined by increased intestinal permeability that permits particles to pass through the gastrointestinal wall. Probiotics, may be able to improve intestinal barrier function. OBJECTIVE: To test whether probiotics, as adjucnt therapy, can reduce incidence and severity of migraine attacks by reducing intestinal permeability.
Given the significant unmet need for improved therapies that address migraine disorders and concurrent irritable bowel syndrome (IBS), this study seeks to investigate the impact of probiotics on the sequelae of symptoms associated with both migraine and IBS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
Probiotic Capsules in blister packets of capsules containing the probiotic intervention contain a combination of three strains of lactic acid bacteria: two Lactobacillus plantarum (CECT7484 and CECT7485) and one Pediococcus acidilactici (CECT7483).
Placebo Capsules in blister packets of capsules containing the inert (controlled) non-interventional treatment.
Scripps Center for Integrative Medicine
La Jolla, California, United States
RECRUITINGReduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score
This survey measures headache frequency, disability, severity
Time frame: Change day 0 to week 12
Improved Quality of Life (QoL) and reduced depressive symptoms (per Patient Health Questionnaire (PHQ-9))
Survey used to assess depressive symptoms
Time frame: Change day 0 to week 12
Reduced severity of Gastrointestinal (GI) symptoms (per Irritable Bowel Syndrome Severity Scoring System (IBS -SSS))
Survey used to assess IBS symptoms
Time frame: Change day 0 to week 12
Reduced generalized anxiety (per Generalized Anxiety Disorder (GAD-7))
Survey used to assess anxiety symptoms
Time frame: Change day 0 to week 12
Reduce headache parameters (headache episodes, headache days, intensity, duration) based on MIDAS subcomponents and journal/diary
Survey used to assess migraine treatments symptoms
Time frame: Change day 0 to week 12
Change in acute medication requirements
Survey used to assess medication requirements
Time frame: Change day 0 to week 12
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