MigraineNCT04696458
Effects of a Multispecies Probiotic on Migraine
A study testing Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483) in people with Migraine and Irritable Bowel Syndrome, run by Scripps Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine, Irritable Bowel Syndrome, Headache, Migraine
- What is being tested?
- Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Scripps Center for Integrative Medicine
La Jolla, California, 92307
Monica Dutta, 858-554-9894, dutta.monica@scrippshealth.org
Robert Bonakdar, 8585543300, bonakdar.robert@scrippshealth.org
About this study
Official title: Effects of a Multispecies Probiotic on Migraine: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Migraine, Irritable Bowel Syndrome, Headache, Migraine
- Being tested
- Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483), Placebo Comparator: Placebo
- Keywords
- Probiotics, Headache Disorders, Migraine Disorders, Pain, Digestive System Diseases, Neurologic Manifestations, Gut-Brain Axis, Microbiome, Functional Gastrointestinal Symptoms
- Medical subject headings
- Migraine Disorders, Irritable Bowel Syndrome, Headache Disorders, Pain, Digestive System Diseases, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)Dietary supplement
Also called Placebo Comparator: Placebo
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).
Placebo Comparator: PlaceboOther
Also called inert placebo
Placebo Capsules in blister packets of capsules containing the inert (controlled) non-interventional treatment.
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL PROBIOTIC | Experimental | 1 Multistrain Probiotic Capsule Receives: Dietary Supplement: Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483) |
| Placebo | Placebo comparator | 1 Identical Placebo Capsule Receives: Other: Placebo Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score
This survey measures headache frequency, disability, severity
Measured: Change day 0 to week 12
Secondary outcomes (5)
Improved Quality of Life (QoL) and reduced depressive symptoms (per Patient Health Questionnaire (PHQ-9))
Survey used to assess depressive symptoms
Measured: Change day 0 to week 12
Reduced severity of Gastrointestinal (GI) symptoms (per Irritable Bowel Syndrome Severity Scoring System (IBS -SSS))
Survey used to assess IBS symptoms
Measured: Change day 0 to week 12
Reduced generalized anxiety (per Generalized Anxiety Disorder (GAD-7))
Survey used to assess anxiety symptoms
Measured: Change day 0 to week 12
Reduce headache parameters (headache episodes, headache days, intensity, duration) based on MIDAS subcomponents and journal/diary
Survey used to assess migraine treatments symptoms
Measured: Change day 0 to week 12
Change in acute medication requirements
Survey used to assess medication requirements
Measured: Change day 0 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start15 Apr 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Collaborators
- Kaneka Corporation
- Responsible party
- Sponsor
- Investigators
- Megan Sweeney, MPH, Study chair, Scripps ClinicKristen Hickey, Study chair, Scripps Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696458
- Sponsor's protocol ID
- IRB-21-7729
- Status last verified
- Nov 2022
- First submitted
- 4 Jan 2021
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data and information can be shared upon request after study completion
Publications
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.
PubMed 32054443Dai 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.
PubMed 28158162Loren 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.
PubMed 27832441Lorenzo-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.
PubMed 25024629Naghibi 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.
PubMed 31514352National Institute of Neurological Disorders and Stroke. Headache: Hope Through Research. April 2016.
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multispecies Probiotic on Migraine: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04696458
- Acronym / sponsor ID
- IRB-21-7729
- Conditions
- Migraine, Irritable Bowel Syndrome, Headache, Migraine
- Keywords
- Probiotics, Headache Disorders, Migraine Disorders, Pain, Digestive System Diseases, Neurologic Manifestations, Gut-Brain Axis, Microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Collaborators
- Kaneka Corporation
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL PROBIOTIC | Experimental | Dietary Supplement: Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)1 Multistrain Probiotic Capsule |
| Placebo | Placebo comparator | Other: Placebo Comparator: Placebo1 Identical Placebo Capsule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)Also: Placebo Comparator: PlaceboProbiotic 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). | Dietary supplement | EXPERIMENTAL PROBIOTIC |
| Placebo Comparator: PlaceboAlso: inert placeboPlacebo Capsules in blister packets of capsules containing the inert (controlled) non-interventional treatment. | Other | Placebo |
Primary outcome
Reduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score
Time frame: Change day 0 to week 12
This survey measures headache frequency, disability, severity
5 secondary outcomes
Improved Quality of Life (QoL) and reduced depressive symptoms (per Patient Health Questionnaire (PHQ-9))
Time frame: Change day 0 to week 12
Reduced severity of Gastrointestinal (GI) symptoms (per Irritable Bowel Syndrome Severity Scoring System (IBS -SSS))
Time frame: Change day 0 to week 12
Reduced generalized anxiety (per Generalized Anxiety Disorder (GAD-7))
Time frame: Change day 0 to week 12
Reduce headache parameters (headache episodes, headache days, intensity, duration) based on MIDAS subcomponents and journal/diary
Time frame: Change day 0 to week 12
Change in acute medication requirements
Time frame: Change day 0 to week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Background: PubMed 32054443Arzani 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.
- Background: PubMed 28158162Dai 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.
- Background: PubMed 27832441Loren 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.
- Background: PubMed 25024629Lorenzo-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.
- Background: PubMed 31514352Naghibi 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.
- BackgroundNational Institute of Neurological Disorders and Stroke. Headache: Hope Through Research. April 2016.
- Individual participant dataSharing planned: Yes. De-identified study data and information can be shared upon request after study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Sweeney, MPH study chair
Scripps Clinic
Kristen Hickey study chair
Scripps Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483) in people with Migraine and Irritable Bowel Syndrome, run by Scripps Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Bonakdar, MD (858-554-3300, bonakdar.robert@scrippshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Migraine-induced Disability as measured by the Migraine Induced Disability Assessment Score (MIDAS) total score (time frame: Change day 0 to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04696458, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.