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NCT04305522 | Unknown status | Migraine

Probiotics for the Prophylaxis of Migraine
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.

Condition or disease

Migraine

Intervention/treatment

Probiotic 1

Placebo

Probiotic 2

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 75 participants
Masking : Double
Masking Description : Double-blind
Primary Purpose : Treatment
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
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : February 2, 2021
Estimated Study Completion Date : May 2, 2021
Arm Intervention/treatment

Experimental: Probiotic 1 group

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

Dietary Supplement: Probiotic 1

Experimental: Probiotic 2 group

A multi-strain probiotic

Dietary Supplement: Probiotic 2

Placebo Comparator: Placebo group

Identical placebo

Dietary Supplement: Placebo
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Age between 18 - 65 years.
  • Signature of informed consent by the patient.
  • Patients with confirmed migraine, diagnosed by a neurologist
  • Patient-indicated frequency of migraine attacks (or days) of at least 4 per month.
  • Fairly predictable and stable pattern of migraine attacks (frequency, duration, intensity)
Exclusion Criteria
  • Patients diagnosed with chronic migraine
  • Migraine patients suffering from medication-dependent headaches.
  • Patients suffering from cluster or tension-related headaches.
  • Patients who used antibiotics up to two weeks before the start of the study.
  • Patients who have taken other probiotics in the previous two months.
  • Patients with chronic use of non-steroidal anti-inflammatory drugs.
  • Patients with inflammatory bowel disease (due to increased intestinal permeability).
  • Patients who are pregnant, breastfeeding or who do not commit to using an effective method of contraception during the course of the study.
Probiotics for the Prophylaxis of Migraine

Location Details

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Probiotics for the Prophylaxis of Migraine

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Spain, Alicante

Vinalopó University Hospital

Elche, Alicante, Spain, 03293

Not yet recruiting

Spain, Alicante

Torrevieja University Hospital

Torrevieja, Alicante, Spain, 03186