Effects of a Multispecies Probiotic on Migraine

Migraine Clinical Trial

Official title:

Effects of a Multispecies Probiotic on Migraine: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04696458
• Other study ID #: IRB-21-7729
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: November 2022
• Source: Scripps Health
• Contact: Robert Bonakdar, MD
• Phone: 858-554-3300
• Email: bonakdar.robert[@]scrippshealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Headache, Migraine
• Irritable Bowel Syndrome
• Migraine
• Migraine Disorders

Intervention

Dietary Supplement:
• 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).

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

Locations

Country	Name	City	State
United States	Scripps Center for Integrative Medicine	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Health	Kaneka Corporation

Country where clinical trial is conducted

United States, 

References & 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. Review. — View 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. Review. — View Citation

Lorén V, Manyé J, Fuentes MC, Cabré 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. — View Citation

Lorenzo-Zúñiga V, Llop E, Suárez 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. — View 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). pii: E1441. doi: 10.3390/jcm8091441. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Reduced severity of Gastrointestinal (GI) symptoms (per Irritable Bowel Syndrome Severity Scoring System (IBS -SSS))	Survey used to assess IBS symptoms	Change day 0 to week 12
Secondary	Reduced generalized anxiety (per Generalized Anxiety Disorder (GAD-7))	Survey used to assess anxiety symptoms	Change day 0 to week 12
Secondary	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
Secondary	Change in acute medication requirements	Survey used to assess medication requirements	Change day 0 to week 12