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Search / Trial NCT04696458

Effects of a Multispecies Probiotic on Migraine

Launched by SCRIPPS HEALTH · Jan 4, 2021

Trial Information

Current as of June 22, 2025

Unknown status

Keywords

Probiotics Headache Disorders Migraine Disorders Pain Digestive System Diseases Neurologic Manifestations Gut Brain Axis Microbiome Functional Gastrointestinal Symptoms

ClinConnect Summary

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.

Gender

ALL

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

About Scripps Health

Scripps Health is a leading nonprofit healthcare organization based in San Diego, California, dedicated to advancing medical research and improving patient care through innovative clinical trials. With a commitment to excellence, Scripps Health integrates cutting-edge technology and evidence-based practices to explore new treatments and therapies across various medical disciplines. Their robust network of healthcare professionals and research specialists fosters a collaborative environment, enabling the development of groundbreaking solutions that enhance health outcomes for diverse patient populations. Through rigorous scientific inquiry and a patient-centered approach, Scripps Health continues to contribute significantly to the advancement of medical knowledge and the improvement of community health.

Locations

La Jolla, California, United States

Patients applied

0 patients applied

Trial Officials

Megan Sweeney, MPH

Study Chair

Scripps Clinic

Kristen Hickey

Study Chair

Scripps Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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