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Effects of a Multispecies Probiotic on Migraine

NCT04696458 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-11-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Kaneka Corporation

    collaborator INDUSTRY

  • Scripps Health

    lead OTHER

Principal Investigators

  • Megan Sweeney, MPH · Scripps Clinic

  • Kristen Hickey · Scripps Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2023-12-31
Completion
2024-04-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04696458 on ClinicalTrials.gov