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Effects of a Multispecies Probiotic on Migraine

Primary Purpose

Migraine, Irritable Bowel Syndrome, Headache, Migraine

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)
Placebo Comparator: Placebo
Sponsored by
Scripps Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine focused on measuring Probiotics, Headache Disorders, Migraine Disorders, Pain, Digestive System Diseases, Neurologic Manifestations, Gut-Brain Axis, Microbiome, Functional Gastrointestinal Symptoms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Center for Integrative MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EXPERIMENTAL PROBIOTIC

Placebo

Arm Description

1 Multistrain Probiotic Capsule

1 Identical Placebo Capsule

Outcomes

Primary Outcome Measures

Reduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score
This survey measures headache frequency, disability, severity

Secondary Outcome Measures

Improved Quality of Life (QoL) and reduced depressive symptoms (per Patient Health Questionnaire (PHQ-9))
Survey used to assess depressive symptoms
Reduced severity of Gastrointestinal (GI) symptoms (per Irritable Bowel Syndrome Severity Scoring System (IBS -SSS))
Survey used to assess IBS symptoms
Reduced generalized anxiety (per Generalized Anxiety Disorder (GAD-7))
Survey used to assess anxiety symptoms
Reduce headache parameters (headache episodes, headache days, intensity, duration) based on MIDAS subcomponents and journal/diary
Survey used to assess migraine treatments symptoms
Change in acute medication requirements
Survey used to assess medication requirements

Full Information

First Posted
January 4, 2021
Last Updated
November 21, 2022
Sponsor
Scripps Health
Collaborators
Kaneka Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04696458
Brief Title
Effects of a Multispecies Probiotic on Migraine
Official Title
Effects of a Multispecies Probiotic on Migraine: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scripps Health
Collaborators
Kaneka Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EXPERIMENTAL PROBIOTIC
Arm Type
Experimental
Arm Description
1 Multistrain Probiotic Capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 Identical Placebo Capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)
Other Intervention Name(s)
Placebo Comparator: Placebo
Intervention 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).
Intervention Type
Other
Intervention Name(s)
Placebo Comparator: Placebo
Other Intervention Name(s)
inert placebo
Intervention Description
Placebo Capsules in blister packets of capsules containing the inert (controlled) non-interventional treatment.
Primary Outcome Measure Information:
Title
Reduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score
Description
This survey measures headache frequency, disability, severity
Time Frame
Change day 0 to week 12
Secondary Outcome Measure Information:
Title
Improved Quality of Life (QoL) and reduced depressive symptoms (per Patient Health Questionnaire (PHQ-9))
Description
Survey used to assess depressive symptoms
Time Frame
Change day 0 to week 12
Title
Reduced severity of Gastrointestinal (GI) symptoms (per Irritable Bowel Syndrome Severity Scoring System (IBS -SSS))
Description
Survey used to assess IBS symptoms
Time Frame
Change day 0 to week 12
Title
Reduced generalized anxiety (per Generalized Anxiety Disorder (GAD-7))
Description
Survey used to assess anxiety symptoms
Time Frame
Change day 0 to week 12
Title
Reduce headache parameters (headache episodes, headache days, intensity, duration) based on MIDAS subcomponents and journal/diary
Description
Survey used to assess migraine treatments symptoms
Time Frame
Change day 0 to week 12
Title
Change in acute medication requirements
Description
Survey used to assess medication requirements
Time Frame
Change day 0 to week 12

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Bonakdar, MD
Phone
858-554-3300
Email
bonakdar.robert@scrippshealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Dutta
Phone
858-554-9894
Email
dutta.monica@scrippshealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Sweeney, MPH
Organizational Affiliation
Scripps Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kristen Hickey
Organizational Affiliation
Scripps Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Scripps Center for Integrative Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Dutta
Phone
858-554-9894
Email
dutta.monica@scrippshealth.org
First Name & Middle Initial & Last Name & Degree
Robert Bonakdar
Phone
8585543300
Email
bonakdar.robert@scrippshealth.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified study data and information can be shared upon request after study completion
IPD Sharing Time Frame
6 Months after Study Publication. Can be shared indefinitely
IPD Sharing Access Criteria
Email to PI or study director requesting data. Only secure data will be sent via a secure password protected document.
Citations:
PubMed Identifier
32054443
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.
Results Reference
background
PubMed Identifier
28158162
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.
Results Reference
background
PubMed Identifier
27832441
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.
Results Reference
background
PubMed Identifier
25024629
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.
Results Reference
background
PubMed Identifier
31514352
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.
Results Reference
background
Citation
National Institute of Neurological Disorders and Stroke. Headache: Hope Through Research. April 2016.
Results Reference
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Effects of a Multispecies Probiotic on Migraine

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