Probiotics for the Prophylaxis of Migraine (MIGR_PRO2)

Biopolis

Status: Unknown

Conditions: Migraine

Treatments: Dietary Supplement: Probiotic 2; Dietary Supplement: Probiotic 1; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04305522

MIGR_PRO.2

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

Probiotic 1 group

Experimental group

Description:

A commercially-available multi-strain probiotic with added magnesium and vitamin B6

Treatment:

Dietary Supplement: Probiotic 1

Probiotic 2 group

Experimental group

Description:

A multi-strain probiotic

Treatment:

Dietary Supplement: Probiotic 2

Placebo group

Placebo Comparator group

Description:

Identical placebo

Treatment:

Dietary Supplement: Placebo