Effects of a Multispecies Probiotic on Migraine
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Migraine, Irritable Bowel Syndrome, Headache, Migraine
In brief
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.
Key facts
- Study ID
- NCT04696458
- Run by
- Scripps Health
- People needed
- 60
- Starts
- 2021-04-15
- Expected to finish
- 2024-04-01
- Last updated by the study team
- 2022-11-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Scripps Center for Integrative Medicine — La Jolla, California, United States (enrolling)
Full record on ClinicalTrials.gov
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