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Probiotics for the Prophylaxis of Migraine

NCT04305522 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-03-12

No results posted yet for this study

Summary

This study aims to understand the efficacy of two probiotic interventions as prophylaxes of migraine symptoms in individuals diagnosed with episodic migraine.

The primary outcome measure will be migraine days per month, but secondary outcome measures such as use of analgesia, the wider impact of migraine (as assessed through the HIT-6 score) will also be assessed. Finally adverse effects will be evaluated.

The study will have three arms: two arms including the two different probiotic preparations and a third placebo arm.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotic 1

Probiotic mixture with maltodextrin as a carrier.

DIETARY_SUPPLEMENT

Placebo

Placebo comparator with maltodextrin as a carrier.

DIETARY_SUPPLEMENT

Probiotic 2

Probiotic mixture with maltodextrin as a carrier.

Sponsors & Collaborators

  • Biopolis S.L.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2021-02-02
Completion
2021-05-02

Countries

  • Spain

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 NCT04305522 on ClinicalTrials.gov