Effects of a Multispecies Probiotic on Migraine

Not Applicable

Recruiting

• Conditions: Migraine; Irritable Bowel Syndrome; Headache, Migraine
• Interventions: Dietary Supplement: Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)

• Registration Number: NCT04696458
• Lead Sponsor: Scripps Health

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.

Study Timeline

• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Study Start: 2021-04-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-23
• Primary Completion: 2023-12-31
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EXPERIMENTAL PROBIOTIC	Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)	1 Multistrain Probiotic Capsule

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Change in acute medication requirements	Change day 0 to week 12	Survey used to assess medication requirements
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

Trial Locations

Locations (1)

Scripps Center for Integrative Medicine; 🇺🇸 La Jolla, California, United States