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| Name | Class |
|---|---|
| Kaneka Corporation | INDUSTRY |
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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.
Given the significant unmet need for improved therapies that address migraine disorders and concurrent irritable bowel syndrome (IBS), this study seeks to investigate the impact of probiotics on the sequelae of symptoms associated with both migraine and IBS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPERIMENTAL PROBIOTIC | Experimental | 1 Multistrain Probiotic Capsule |
|
| Placebo | Placebo Comparator | 1 Identical Placebo Capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483) | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score | This survey measures headache frequency, disability, severity | Change day 0 to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Improved Quality of Life (QoL) and reduced depressive symptoms (per Patient Health Questionnaire (PHQ-9)) | Survey used to assess depressive symptoms | Change day 0 to week 12 |
| Reduced severity of Gastrointestinal (GI) symptoms (per Irritable Bowel Syndrome Severity Scoring System (IBS -SSS)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Bonakdar, MD | Contact | 858-554-3300 | bonakdar.robert@scrippshealth.org | |
| Monica Dutta | Contact | 858-554-9894 | dutta.monica@scrippshealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Megan Sweeney, MPH | Scripps Clinic | Study Chair |
| Kristen Hickey | Scripps Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Center for Integrative Medicine | Recruiting | La Jolla | California | 92307 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32054443 | Background | 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. | |
| 28158162 | Background |
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De-identified study data and information can be shared upon request after study completion
6 Months after Study Publication. Can be shared indefinitely
Email to PI or study director requesting data. Only secure data will be sent via a secure password protected document.
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D043183 | Irritable Bowel Syndrome |
| D020773 | Headache Disorders |
| D010146 | Pain |
| D004066 | Digestive System Diseases |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
|
| Placebo Comparator: Placebo | Other | Placebo Capsules in blister packets of capsules containing the inert (controlled) non-interventional treatment. |
|
|
Survey used to assess IBS symptoms |
| Change day 0 to week 12 |
| Reduced generalized anxiety (per Generalized Anxiety Disorder (GAD-7)) | Survey used to assess anxiety symptoms | Change day 0 to week 12 |
| Reduce headache parameters (headache episodes, headache days, intensity, duration) based on MIDAS subcomponents and journal/diary | Survey used to assess migraine treatments symptoms | Change day 0 to week 12 |
| Change in acute medication requirements | Survey used to assess medication requirements | Change day 0 to week 12 |
| 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. |
| 27832441 | Background | 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. |
| 25024629 | Background | 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. |
| 31514352 | Background | 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. |
| Background | National Institute of Neurological Disorders and Stroke. Headache: Hope Through Research. April 2016. |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |