Effects of a Multispecies Probiotic on Migraine

NCT04696458 | Unknown DMC

• 1 other identifier: IRB-21-7729
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Improved Quality of Life (QoL) and reduced depressive symptoms (per Patient Health Questionnaire (PHQ-9))

  Change day 0 to week 12

• Reduced severity of Gastrointestinal (GI) symptoms (per Irritable Bowel Syndrome Severity Scoring System (IBS -SSS))

  Change day 0 to week 12

• Reduced generalized anxiety (per Generalized Anxiety Disorder (GAD-7))

  Change day 0 to week 12

• Reduce headache parameters (headache episodes, headache days, intensity, duration) based on MIDAS subcomponents and journal/diary

  Change day 0 to week 12

• Change in acute medication requirements

  Change day 0 to week 12

Study Arms (2)

EXPERIMENTAL PROBIOTIC

EXPERIMENTAL

1 Multistrain Probiotic Capsule

Dietary Supplement: Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)

Placebo

PLACEBO COMPARATOR

1 Identical Placebo Capsule

Other: Placebo Comparator: Placebo

Interventions

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).

Also known as: Placebo Comparator: Placebo

EXPERIMENTAL PROBIOTIC

Placebo Comparator: Placebo OTHER

Placebo Capsules in blister packets of capsules containing the inert (controlled) non-interventional treatment.

Also known as: inert placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scripps Health: lead
• Kaneka Corporation: collaborator

Study Sites (1)

Scripps Center for Integrative Medicine

La Jolla, California, 92307, United States

RECRUITING

Related Publications (6)

• 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: 32054443 BACKGROUND

• 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: 28158162 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.

  PMID: 27832441 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.

  PMID: 25024629 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.

  PMID: 31514352 BACKGROUND

• National Institute of Neurological Disorders and Stroke. Headache: Hope Through Research. April 2016.

  BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Irritable Bowel Syndrome; Headache Disorders; Pain; Digestive System Diseases; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Megan Sweeney, MPH

  Scripps Clinic

  STUDY CHAIR

• Kristen Hickey

  Scripps Clinic

  STUDY CHAIR

Central Study Contacts

Robert Bonakdar, MD

CONTACT

858-554-3300; bonakdar.robert@scrippshealth.org

Monica Dutta

CONTACT

858-554-9894; dutta.monica@scrippshealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: April 15, 2021
• Primary Completion: December 31, 2023
• Study Completion: April 1, 2024
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 Months after Study Publication. Can be shared indefinitely
• Access Criteria: Email to PI or study director requesting data. Only secure data will be sent via a secure password protected document.

Locations

US (1)