Effects of a Multispecies Probiotic on Migraine

Scripps Health

Status: Enrolling

Conditions: Irritable Bowel Syndrome; Migraine; Headache, Migraine

Treatments: Other: Placebo Comparator: Placebo; Dietary Supplement: Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04696458

IRB-21-7729

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

EXPERIMENTAL PROBIOTIC

Experimental group

Description:

1 Multistrain Probiotic Capsule

Treatment:

Dietary Supplement: Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)

Placebo

Placebo Comparator group

Description:

1 Identical Placebo Capsule

Treatment:

Other: Placebo Comparator: Placebo