Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT04696458
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04696458
Study Brief:
Protocol Section:
NCT04696458