Probiotics for the Prophylaxis of Migraine

Not Applicable

• Conditions: Migraine

• Registration Number: NCT04305522
• Lead Sponsor: Biopolis S.L.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-02
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-11
• Last Update Submitted: 2020-03-11
• Study First Posted: 2020-03-12
• Last Update Posted: 2020-03-12
• Primary Completion: 2021-02-02
• Study Completion: 2021-05-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of days with migraine episodes	12-week	Number of days with migraine episodes, in weeks 12.

Secondary Outcome Measures

Name	Time	Method
Treatment adherence rate	12 weeks	Treatment adherence rate using the returned capsules.
Adherence to the treatment.	12 weeks	Percentage of treatment intake days.
Number of migraine episodes	12 weeks	Number of migraine episodes, in weeks 12.
Headache Impact Test (HIT-6) score	12 weeks	Headache Impact Test (HIT-6) score at weeks 12 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78)
Number of adverse events	12 weeks	Numbre od adverse effects reported
Number of days that each patient requires the administration analgesia	12 weeks	Number of days that each patient requires the administration analgesia, in weeks 12

Trial Locations

Locations (2)

Hospital Universitario del Vinalopó; 🇪🇸 Elche, Alicante, Spain

Hospital Universitario de Torrevieja; 🇪🇸 Torrevieja, Alicante, Spain