Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-04-15
2024-04-01
Brief Summary
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OBJECTIVE: To test whether probiotics, as adjucnt therapy, can reduce incidence and severity of migraine attacks by reducing intestinal permeability.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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EXPERIMENTAL PROBIOTIC
1 Multistrain Probiotic Capsule
Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)
Probiotic Capsules in blister packets of capsules containing the probiotic intervention contain a combination of three strains of lactic acid bacteria: two Lactobacillus plantarum (CECT7484 and CECT7485) and one Pediococcus acidilactici (CECT7483).
Placebo
1 Identical Placebo Capsule
Placebo Comparator: Placebo
Placebo Capsules in blister packets of capsules containing the inert (controlled) non-interventional treatment.
Interventions
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Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)
Probiotic Capsules in blister packets of capsules containing the probiotic intervention contain a combination of three strains of lactic acid bacteria: two Lactobacillus plantarum (CECT7484 and CECT7485) and one Pediococcus acidilactici (CECT7483).
Placebo Comparator: Placebo
Placebo Capsules in blister packets of capsules containing the inert (controlled) non-interventional treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Kaneka Corporation
INDUSTRY
Scripps Health
OTHER
Responsible Party
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Principal Investigators
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Megan Sweeney, MPH
Role: STUDY_CHAIR
Scripps Clinic
Kristen Hickey
Role: STUDY_CHAIR
Scripps Clinic
Locations
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Scripps Center for Integrative Medicine
La Jolla, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Arzani M, Jahromi SR, Ghorbani Z, Vahabizad F, Martelletti P, Ghaemi A, Sacco S, Togha M; School of Advanced Studies of the European Headache Federation (EHF-SAS). Gut-brain Axis and migraine headache: a comprehensive review. J Headache Pain. 2020 Feb 13;21(1):15. doi: 10.1186/s10194-020-1078-9.
Dai YJ, Wang HY, Wang XJ, Kaye AD, Sun YH. Potential Beneficial Effects of Probiotics on Human Migraine Headache: A Literature Review. Pain Physician. 2017 Feb;20(2):E251-E255.
Loren V, Manye J, Fuentes MC, Cabre E, Ojanguren I, Espadaler J. Comparative Effect of the I3.1 Probiotic Formula in Two Animal Models of Colitis. Probiotics Antimicrob Proteins. 2017 Mar;9(1):71-80. doi: 10.1007/s12602-016-9239-5.
Lorenzo-Zuniga V, Llop E, Suarez C, Alvarez B, Abreu L, Espadaler J, Serra J. I.31, a new combination of probiotics, improves irritable bowel syndrome-related quality of life. World J Gastroenterol. 2014 Jul 14;20(26):8709-16. doi: 10.3748/wjg.v20.i26.8709.
Naghibi MM, Day R, Stone S, Harper A. Probiotics for the Prophylaxis of Migraine: A Systematic Review of Randomized Placebo Controlled Trials. J Clin Med. 2019 Sep 11;8(9):1441. doi: 10.3390/jcm8091441.
National Institute of Neurological Disorders and Stroke. Headache: Hope Through Research. April 2016.
Other Identifiers
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IRB-21-7729
Identifier Type: -
Identifier Source: org_study_id
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