Effects of a Multispecies Probiotic on Migraine

Scripps Health60 enrolled

Overview

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

Conditions

Migraine Irritable Bowel Syndrome Headache, Migraine

Interventions

Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)DIETARY_SUPPLEMENT

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 Comparator: PlaceboOTHER

Placebo Capsules in blister packets of capsules containing the inert (controlled) non-interventional treatment.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Episodic migraine diagnosis for a minimum of 1 year (12-months) * Between 3-12 migraine episodes /month * Comorbid, symptomatic, irritable bowel syndrome during the screening period * On a steady treatment regimen: preventative and acute migraine medications and therapies unchanged over the last 6 months * Access to Scripps Center for Integrative Medicine * Access to smartphone or computer to complete electronic surveys Exclusion Criteria: * Other GI or hepatic diagnoses (Inflammatory Bowel Disease (IBD), Small Intestinal Bacterial Overgrowth (SIBO), Non-Alcoholic Fatty Liver Disease (NAFLD), elevated Liver Function Tests (LFTs) within the last 6 months) * Prior GI surgery * Prior GI infection in the previous 3-months * Antibiotic treatment in previous last 3 months * Diagnosed Autoimmune disease * Current corticosteroids use * Morbid obesity (BMI \>40) * Took Probiotics or Probiotic-containing supplements or therapy in the previous 3-months * Diagnosis of post-traumatic headache or cervicogenic headache * Pregnancy or plans to become pregnant during study participation

Locations (1)

Scripps Center for Integrative Medicine

La Jolla, California, United States

RECRUITING

Outcomes

Primary Outcomes

Reduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score

This survey measures headache frequency, disability, severity