Probiotics for the Prophylaxis of Migraine

Biopolis S.L.75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Migraine

Interventions

Probiotic 1DIETARY_SUPPLEMENT

Probiotic mixture with maltodextrin as a carrier.

PlaceboDIETARY_SUPPLEMENT

Placebo comparator with maltodextrin as a carrier.

Probiotic 2DIETARY_SUPPLEMENT

Probiotic mixture with maltodextrin as a carrier.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age between 18 - 65 years. 2. Signature of informed consent by the patient. 3. Patients with confirmed migraine, diagnosed by a neurologist 4. Patient-indicated frequency of migraine attacks (or days) of at least 4 per month. 5. Fairly predictable and stable pattern of migraine attacks (frequency, duration, intensity) Exclusion Criteria: 1. Patients diagnosed with chronic migraine 2. Migraine patients suffering from medication-dependent headaches. 3. Patients suffering from cluster or tension-related headaches. 4. Patients who used antibiotics up to two weeks before the start of the study. 5. Patients who have taken other probiotics in the previous two months. 6. Patients with chronic use of non-steroidal anti-inflammatory drugs. 7. Patients with inflammatory bowel disease (due to increased intestinal permeability). 8. Patients who are pregnant, breastfeeding or who do not commit to using an effective method of contraception during the course of the study.

Locations (2)

Hospital Universitario del Vinalopó

Elche, Alicante, Spain

Hospital Universitario de Torrevieja

Torrevieja, Alicante, Spain

Outcomes

Primary Outcomes

Number of days with migraine episodes

Number of days with migraine episodes in weeks 4

Time frame: 4-week

Number of days with migraine episodes

Number of days with migraine episodes, in weeks 8

Time frame: 8-week

Number of days with migraine episodes

Number of days with migraine episodes, in weeks 12.

Time frame: 12-week

Secondary Outcomes

Number of migraine episodes

Number of migraine episodes, in weeks 4

Time frame: 4 weeks

Number of migraine episodes

Number of migraine episodes, in weeks 8

Time frame: 8 weeks

Number of migraine episodes

Number of migraine episodes, in weeks 12.

Time frame: 12 weeks

Number of days that each patient requires the administration analgesia

Number of days that each patient requires the administration analgesia, in weeks 4

Time frame: 4 weeks

Number of days that each patient requires the administration analgesia

Number of days that each patient requires the administration analgesia, in weeks 8

Time frame: 8 weeks

Number of days that each patient requires the administration analgesia

Central Contacts

María Empar Chenoll, PhD

CONTACT

+34 673 53 53 44 maria.chenoll@adm.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.