Status:
UNKNOWN
Effects of a Multispecies Probiotic on Migraine
Lead Sponsor:
Scripps Health
Collaborating Sponsors:
Kaneka Corporation
Conditions:
Migraine
Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
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 t...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04696458
Start Date
April 15 2021
End Date
April 1 2024
Last Update
November 23 2022
Active Locations (1)
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1
Scripps Center for Integrative Medicine
La Jolla, California, United States, 92307