Effects of a Multispecies Probiotic on Migraine

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Effects of a Multispecies Probiotic on Migraine: A Randomized Controlled Trial

Conditions
-----------------
Migraine, Irritable Bowel Syndrome, Headache, Migraine

Intervention / Treatment
-----------------
* Dietary Supplement: Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)
* Other: Placebo Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPERIMENTAL PROBIOTIC<br>1 Multistrain Probiotic Capsule | Dietary Supplement: Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)<br>* 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).<br>* Other names: Placebo Comparator: Placebo;|
| Placebo Comparator: Placebo<br>1 Identical Placebo Capsule | Other: Placebo Comparator: Placebo<br>* Placebo Capsules in blister packets of capsules containing the inert (controlled) non-interventional treatment.<br>* Other names: inert placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score | This survey measures headache frequency, disability, severity | Change day 0 to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Quality of Life (QoL) and reduced depressive symptoms (per Patient Health Questionnaire (PHQ-9)) | Survey used to assess depressive symptoms | 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 | Change day 0 to week 12 | 
| Reduced generalized anxiety (per Generalized Anxiety Disorder (GAD-7)) | Survey used to assess anxiety symptoms | 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 | Change day 0 to week 12 | 
| Change in acute medication requirements | Survey used to assess medication requirements | Change day 0 to week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotics, Headache Disorders, Migraine Disorders, Pain, Digestive System Diseases, Neurologic Manifestations, Gut-Brain Axis, Microbiome, Functional Gastrointestinal Symptoms