Clinical trial NCT04305522: Probiotics for the Prophylaxis of Migraine
Official title: A Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Two Probiotic Interventions For The Prophylaxis of Migraine in Patients Diagnosed With Episodic Migraine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Keywords: Probiotic
Migraine
Lead sponsor: Biopolis S.L.
Sponsor class: INDUSTRY
First posted: 2020-03-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of days with migraine episodes
timeFrame: 4-week
measure: Number of days with migraine episodes
timeFrame: 8-week
measure: Number of days with migraine episodes
timeFrame: 12-week
Secondary outcomes:
measure: Number of migraine episodes
timeFrame: 4 weeks
measure: Number of migraine episodes
timeFrame: 8 weeks
measure: Number of migraine episodes
timeFrame: 12 weeks
measure: Number of days that each patient requires the administration analgesia
timeFrame: 4 weeks
measure: Number of days that each patient requires the administration analgesia
timeFrame: 8 weeks
measure: Number of days that each patient requires the administration analgesia
timeFrame: 12 weeks
measure: Headache Impact Test (HIT-6) score
timeFrame: 4 weeks
measure: Headache Impact Test (HIT-6) score
timeFrame: 8 weeks
measure: Headache Impact Test (HIT-6) score
timeFrame: 12 weeks
measure: Treatment adherence rate
timeFrame: 12 weeks
measure: Number of adverse events
timeFrame: 12 weeks
measure: Adherence to the treatment.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital Universitario del Vinalopó
state: Alicante
city: Torrevieja
country: Spain
facility: Hospital Universitario de Torrevieja
state: Alicante
Study officials:
References: