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Probiotics for Migraine

N/A
Waitlist Available
Research Sponsored by Scripps Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Episodic migraine diagnosis for a minimum of 1 year (12-months)
Comorbid, symptomatic, irritable bowel syndrome during the screening period
Must not have
Diagnosed Autoimmune disease
Prior GI surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change day 0 to week 12

Summary

This trialwill look at whether taking probiotics can reduce migraine incidence and severity by improving the gut's ability to keep particles from passing through.

Who is the study for?
This trial is for people who've had episodic migraines for at least a year, with 3-12 episodes per month, and also have irritable bowel syndrome. Participants should be on a stable migraine treatment plan for the last 6 months and able to complete surveys online. Pregnant individuals, those planning pregnancy, recent GI infections or antibiotic use, autoimmune diseases, morbid obesity, or prior probiotic use are excluded.
What is being tested?
The study is testing if multispecies probiotics can reduce the frequency and severity of migraine attacks by improving gut health in patients with both migraines and IBS. One group will receive the probiotics while another will get a placebo (a substance with no active drug) to compare outcomes.
What are the potential side effects?
Probiotics are generally considered safe but may cause digestive side effects like gas or bloating initially. Rarely they might lead to infection in very sensitive individuals or those with weakened immune systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with episodic migraines for at least a year.
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I have symptoms of irritable bowel syndrome currently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with an autoimmune disease.
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I have had surgery on my digestive system before.
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I have taken probiotics or probiotic supplements in the last 3 months.
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I have been diagnosed with a headache due to injury or neck issues.
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I have not taken antibiotics in the last 3 months.
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I am currently taking corticosteroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change day 0 to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and change day 0 to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score
Secondary study objectives
Change in acute medication requirements
Improved Quality of Life (QoL) and reduced depressive symptoms (per Patient Health Questionnaire (PHQ-9))
Reduce headache parameters (headache episodes, headache days, intensity, duration) based on MIDAS subcomponents and journal/diary
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EXPERIMENTAL PROBIOTICExperimental Treatment1 Intervention
1 Multistrain Probiotic Capsule
Group II: PlaceboPlacebo Group1 Intervention
1 Identical Placebo Capsule

Find a Location

Who is running the clinical trial?

Scripps HealthLead Sponsor
58 Previous Clinical Trials
43,513 Total Patients Enrolled
1 Trials studying Migraine
40 Patients Enrolled for Migraine
Kaneka CorporationIndustry Sponsor
6 Previous Clinical Trials
469 Total Patients Enrolled
Heather Catchpole, MSStudy DirectorScripps Clinic

Media Library

EXPERIMENTAL PROBIOTIC Clinical Trial Eligibility Overview. Trial Name: NCT04696458 — N/A
Migraine Research Study Groups: EXPERIMENTAL PROBIOTIC, Placebo
Migraine Clinical Trial 2023: EXPERIMENTAL PROBIOTIC Highlights & Side Effects. Trial Name: NCT04696458 — N/A
EXPERIMENTAL PROBIOTIC 2023 Treatment Timeline for Medical Study. Trial Name: NCT04696458 — N/A
Migraine Patient Testimony for trial: Trial Name: NCT04696458 — N/A
~13 spots leftby Nov 2025
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