Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT04696458
Status:
UNKNOWN
Last Update Posted:
2022-11-23
First Post:
2021-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Multispecies Probiotic on Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-21', 'studyFirstSubmitDate': '2021-01-04', 'studyFirstSubmitQcDate': '2021-01-04', 'lastUpdatePostDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score', 'timeFrame': 'Change day 0 to week 12', 'description': 'This survey measures headache frequency, disability, severity'}], 'secondaryOutcomes': [{'measure': 'Improved Quality of Life (QoL) and reduced depressive symptoms (per Patient Health Questionnaire (PHQ-9))', 'timeFrame': 'Change day 0 to week 12', 'description': 'Survey used to assess depressive symptoms'}, {'measure': 'Reduced severity of Gastrointestinal (GI) symptoms (per Irritable Bowel Syndrome Severity Scoring System (IBS -SSS))', 'timeFrame': 'Change day 0 to week 12', 'description': 'Survey used to assess IBS symptoms'}, {'measure': 'Reduced generalized anxiety (per Generalized Anxiety Disorder (GAD-7))', 'timeFrame': 'Change day 0 to week 12', 'description': 'Survey used to assess anxiety symptoms'}, {'measure': 'Reduce headache parameters (headache episodes, headache days, intensity, duration) based on MIDAS subcomponents and journal/diary', 'timeFrame': 'Change day 0 to week 12', 'description': 'Survey used to assess migraine treatments symptoms'}, {'measure': 'Change in acute medication requirements', 'timeFrame': 'Change day 0 to week 12', 'description': 'Survey used to assess medication requirements'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Headache Disorders', 'Migraine Disorders', 'Pain', 'Digestive System Diseases', 'Neurologic Manifestations', 'Gut-Brain Axis', 'Microbiome', 'Functional Gastrointestinal Symptoms'], 'conditions': ['Migraine', 'Irritable Bowel Syndrome', 'Headache, Migraine']}, 'referencesModule': {'references': [{'pmid': '32054443', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28158162', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27832441', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25024629', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31514352', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'National Institute of Neurological Disorders and Stroke. Headache: Hope Through Research. April 2016.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nOBJECTIVE: To test whether probiotics, as adjucnt therapy, can reduce incidence and severity of migraine attacks by reducing intestinal permeability.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Episodic migraine diagnosis for a minimum of 1 year (12-months)\n* Between 3-12 migraine episodes /month\n* Comorbid, symptomatic, irritable bowel syndrome during the screening period\n* On a steady treatment regimen: preventative and acute migraine medications and therapies unchanged over the last 6 months\n* Access to Scripps Center for Integrative Medicine\n* Access to smartphone or computer to complete electronic surveys\n\nExclusion Criteria:\n\n* 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)\n* Prior GI surgery\n* Prior GI infection in the previous 3-months\n* Antibiotic treatment in previous last 3 months\n* Diagnosed Autoimmune disease\n* Current corticosteroids use\n* Morbid obesity (BMI \\>40)\n* Took Probiotics or Probiotic-containing supplements or therapy in the previous 3-months\n* Diagnosis of post-traumatic headache or cervicogenic headache\n* Pregnancy or plans to become pregnant during study participation'}, 'identificationModule': {'nctId': 'NCT04696458', 'briefTitle': 'Effects of a Multispecies Probiotic on Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Scripps Health'}, 'officialTitle': 'Effects of a Multispecies Probiotic on Migraine: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB-21-7729'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EXPERIMENTAL PROBIOTIC', 'description': '1 Multistrain Probiotic Capsule', 'interventionNames': ['Dietary Supplement: Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 Identical Placebo Capsule', 'interventionNames': ['Other: Placebo Comparator: Placebo']}], 'interventions': [{'name': 'Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo Comparator: Placebo'], 'description': '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).', 'armGroupLabels': ['EXPERIMENTAL PROBIOTIC']}, {'name': 'Placebo Comparator: Placebo', 'type': 'OTHER', 'otherNames': ['inert placebo'], 'description': 'Placebo Capsules in blister packets of capsules containing the inert (controlled) non-interventional treatment.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92307', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Monica Dutta', 'role': 'CONTACT', 'email': 'dutta.monica@scrippshealth.org', 'phone': '858-554-9894'}, {'name': 'Robert Bonakdar', 'role': 'CONTACT', 'email': 'bonakdar.robert@scrippshealth.org', 'phone': '8585543300'}], 'facility': 'Scripps Center for Integrative Medicine', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'centralContacts': [{'name': 'Robert Bonakdar, MD', 'role': 'CONTACT', 'email': 'bonakdar.robert@scrippshealth.org', 'phone': '858-554-3300'}, {'name': 'Monica Dutta', 'role': 'CONTACT', 'email': 'dutta.monica@scrippshealth.org', 'phone': '858-554-9894'}], 'overallOfficials': [{'name': 'Megan Sweeney, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Scripps Clinic'}, {'name': 'Kristen Hickey', 'role': 'STUDY_CHAIR', 'affiliation': 'Scripps Clinic'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '6 Months after Study Publication. Can be shared indefinitely', 'ipdSharing': 'YES', 'description': 'De-identified study data and information can be shared upon request after study completion', 'accessCriteria': 'Email to PI or study director requesting data. Only secure data will be sent via a secure password protected document.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scripps Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kaneka Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}