Effects of a Multispecies Probiotic on Migraine Headaches

Trial ID:
IRB-21-7729
Robert Alan Bonakdar, M.D.
In this single center, randomized, placebo-controlled clinical trial, adults diagnosed with Episodic Migraine and Irritable Bowel Syndrome will be randomly chosen to receive a once daily, commercially-available probiotic supplement or a placebo for 12-weeks. Two clinic visits and two brief telephone calls with the research coordinator are required over 16-weeks.

Inclusion Criteria

Patients must:

  • Be 18-75 years of age.
  • Have had a documented diagnosis of episodic migraine headaches for a minimum of 1 year.
  • Have an average of 3-12 episodic migraines per month.
  • Have been on a steady treatment regimen for at least 3 months.
  • Be willing to attend 2 in-person visits at Scripps Green Hospital.
  • Have access to a smartphone or computer to complete surveys.

Exclusion Criteria

Patients must not:

  • Have a formally diagnosed GI or hepatic condition (IBD, SIBO, NAFLD).
  • Have had a GI infection in the past 3 months.
  • Be currently taking probiotic supplements.
  • Have taken antibiotics in the previous 3 months.
  • Have a diagnosed active autoimmune disease.
  • Have post-traumatic or cervicogenic headaches.
  • Have had previous gastrointestinal surgeries.
  • Be morbidly obese (BMI >40).
  • Be pregnant or nursing.

Additional Info

Previous studies have reported that probiotic formulations may have a positive influence on the intensity and frequency of migraine headaches.

Study participants will be randomized (like the flip of a coin) to take an over-the-counter multistrain probiotic supplement or a placebo once a day for 12 weeks. The placebo will look like the probiotic but does not contain any active ingredients.

Contact Info:

  • CRS Leadership
  • CRSLeadership@scrippshealth.org