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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change day 0 to week 12
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with episodic migraines for at least a year.
Select...
I have symptoms of irritable bowel syndrome currently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change day 0 to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change day 0 to week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score
Secondary outcome measures
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 moreTrial 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
54 Previous Clinical Trials
11,732 Total Patients Enrolled
1 Trials studying Migraine
40 Patients Enrolled for Migraine
Kaneka CorporationIndustry Sponsor
5 Previous Clinical Trials
189 Total Patients Enrolled
Heather Catchpole, MSStudy DirectorScripps Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with an autoimmune disease.You can go to Scripps Center for Integrative Medicine.I have been diagnosed with episodic migraines for at least a year.I have had surgery on my digestive system before.I have symptoms of irritable bowel syndrome currently.I have had a gastrointestinal infection in the last 3 months.I have taken probiotics or probiotic supplements in the last 3 months.I have been diagnosed with a headache due to injury or neck issues.I have not taken antibiotics in the last 3 months.I have a diagnosed GI or liver condition like IBD, SIBO, NAFLD, or recent high liver tests.My migraine treatment hasn't changed in the last 6 months.I experience 3 to 12 migraines a month.I am currently taking corticosteroids.You have severe obesity with a body mass index (BMI) over 40.
Research Study Groups:
This trial has the following groups:- Group 1: EXPERIMENTAL PROBIOTIC
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Migraine Patient Testimony for trial: Trial Name: NCT04696458 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any eligibility criteria for participating in this clinical trial?
"To be eligible for this trial, potential participants must have a diagnosis of migraine and fall within the age range of 18 to 75. The research team is actively seeking 60 individuals that meet these criteria."
Answered by AI
Does the eligibility criteria of this trial encompass individuals over 35 years old?
"This trial strictly requires all participants to be 18 or older and no more than 75."
Answered by AI
How many participants is this experiment accommodating?
"Yes, the details provided on clinicaltrials.gov confirms that this investigation is actively seeking volunteers. Initially posted in April 2021 and updated last month, it will involve 60 individuals at a single centre."
Answered by AI
Is enrollment for this research project still open to participants?
"Per the information on clinicaltrials.gov, this medical trial is searching for participants at present. It was originally posted on April 15th 2021 and was most recently updated November 21st 2022."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Scripps Center for Integrative Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I just want to get involved with some type of trial ASAP but they either aren't the right ones or have way too long of a wait list and because of that it seems like forever with me trying to get in one I have applied with lots so whoever gets to me first that's who I'm going with!
PatientReceived no prior treatments
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