Headache, Migraine, Irritable Bowel Syndrome, Migraine
Conditions
Keywords
Probiotics, Headache Disorders, Migraine Disorders, Pain, Digestive System Diseases, Neurologic Manifestations, Gut-Brain Axis, Microbiome, Functional Gastrointestinal Symptoms
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)
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.
Sponsors
Kaneka Corporation
Scripps Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score | Change day 0 to week 12 | This survey measures headache frequency, disability, severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improved Quality of Life (QoL) and reduced depressive symptoms (per Patient Health Questionnaire (PHQ-9)) | Change day 0 to week 12 | Survey used to assess depressive symptoms |
| Reduced severity of Gastrointestinal (GI) symptoms (per Irritable Bowel Syndrome Severity Scoring System (IBS -SSS)) | Change day 0 to week 12 | Survey used to assess IBS symptoms |
| Reduced generalized anxiety (per Generalized Anxiety Disorder (GAD-7)) | Change day 0 to week 12 | Survey used to assess anxiety symptoms |
| Reduce headache parameters (headache episodes, headache days, intensity, duration) based on MIDAS subcomponents and journal/diary | Change day 0 to week 12 | Survey used to assess migraine treatments symptoms |
| Change in acute medication requirements | Change day 0 to week 12 | Survey used to assess medication requirements |
Countries
United States
Contacts
Primary ContactRobert Bonakdar, MD
Backup ContactMonica Dutta
Outcome results
None listed