Recruiting

Multispecies Probiotic

Sponsor:

Scripps Health

Code:

NCT04696458

Conditions

Migraine

Irritable Bowel Syndrome

Headache, Migraine

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)

Placebo Comparator: Placebo

Study Details

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

Study ID

NCT04696458

Start date

Apr 15, 2021

Status verified date

Nov, 2022

Completion date

Apr 1, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: EXPERIMENTAL PROBIOTIC

1 Multistrain Probiotic Capsule

placebo comparator: Placebo

1 Identical Placebo Capsule

Interventions

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).

Placebo Comparator: Placebo

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

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 ]

Central Contacts and Locations

Central contacts

Robert Bonakdar, MD

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

Monica Dutta

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

Locations

Scripps Center for Integrative Medicine

Recruiting

La Jolla, California, United States, 92307

Contacts

Monica Dutta

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

Robert Bonakdar

8585543300bonakdar.robert@scrippshealth.org

More Information

Sponsor

Scripps Health

Last update posted

Nov 23, 2022

Last verified

Nov, 2022

Keywords

  • Probiotics
  • Headache Disorders
  • Migraine Disorders
  • Pain
  • Digestive System Diseases
  • Neurologic Manifestations
  • Gut-Brain Axis
  • Microbiome
  • Functional Gastrointestinal Symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Scripps Health on 2022-11-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.