NCT04696458

Effects of a Multispecies Probiotic on Migraine

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Scripps Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine
• Irritable Bowel Syndrome
• Headache, Migraine

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-15
• Primary completion: 2023-12-31
• Completion: 2024-04-01
• First posted: 2021-01-06
• Last updated: 2022-11-23

Locations

1 site across 1 country: United States