Clinical trial NCT04696458: Effects of a Multispecies Probiotic on Migraine
Official title: Effects of a Multispecies Probiotic on Migraine: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Irritable Bowel Syndrome
Headache, Migraine
Keywords: Probiotics
Headache Disorders
Migraine Disorders
Pain
Digestive System Diseases
Neurologic Manifestations
Gut-Brain Axis
Microbiome
Functional Gastrointestinal Symptoms
Lead sponsor: Scripps Health
Sponsor class: OTHER
Collaborators: name: Kaneka Corporation
First posted: 2021-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Episodic migraine diagnosis for a minimum of 1 year (12-months)
* 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:

* 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)
* 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

Primary outcomes:
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
Secondary outcomes:
measure: Improved Quality of Life (QoL) and reduced depressive symptoms (per Patient Health Questionnaire (PHQ-9))
timeFrame: Change day 0 to week 12
measure: Reduced severity of Gastrointestinal (GI) symptoms (per Irritable Bowel Syndrome Severity Scoring System (IBS -SSS))
timeFrame: Change day 0 to week 12
measure: Reduced generalized anxiety (per Generalized Anxiety Disorder (GAD-7))
timeFrame: Change day 0 to week 12
measure: Reduce headache parameters (headache episodes, headache days, intensity, duration) based on MIDAS subcomponents and journal/diary
timeFrame: Change day 0 to week 12
measure: Change in acute medication requirements
timeFrame: Change day 0 to week 12
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Center for Integrative Medicine
state: California
Study officials:
affiliation: Scripps Clinic
name: Megan Sweeney, MPH
role: STUDY_CHAIR
affiliation: Scripps Clinic
name: Kristen Hickey
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
citation: National Institute of Neurological Disorders and Stroke. Headache: Hope Through Research. April 2016.