Probiotics for the Prophylaxis of Migraine (MIGR_PRO2)

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

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 Overview

• Status: Unknown
• Conditions: Migraine
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic 1; Dietary supplement: Probiotic 2

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03293
      • Hospital Universitario del Vinalopó
    • Torrevieja, Alicante, Spain, 03186
      • Hospital Universitario de Torrevieja

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; Identical placebo	Dietary supplement: Placebo; Placebo comparator with maltodextrin as a carrier.
Experimental: Probiotic 1 group; A commercially-available multi-strain probiotic with added magnesium and vitamin B6	Dietary supplement: Probiotic 1; Probiotic mixture with maltodextrin as a carrier.
Experimental: Probiotic 2 group; A multi-strain probiotic	Dietary supplement: Probiotic 2; Probiotic mixture with maltodextrin as a carrier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days with migraine episodes	Number of days with migraine episodes in weeks 4	4-week
Number of days with migraine episodes	Number of days with migraine episodes, in weeks 8	8-week
Number of days with migraine episodes	Number of days with migraine episodes, in weeks 12.	12-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of migraine episodes	Number of migraine episodes, in weeks 4	4 weeks
Number of migraine episodes	Number of migraine episodes, in weeks 8	8 weeks
Number of migraine episodes	Number of migraine episodes, in weeks 12.	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	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	8 weeks
Number of days that each patient requires the administration analgesia	Number of days that each patient requires the administration analgesia, in weeks 12	12 weeks
Headache Impact Test (HIT-6) score	Headache Impact Test (HIT-6) score at weeks 0 and 4 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78)	4 weeks
Headache Impact Test (HIT-6) score	Headache Impact Test (HIT-6) score at weeks 8 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78)	8 weeks
Headache Impact Test (HIT-6) score	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)	12 weeks
Treatment adherence rate	Treatment adherence rate using the returned capsules.	12 weeks
Number of adverse events	Numbre od adverse effects reported	12 weeks
Adherence to the treatment.	Percentage of treatment intake days.	12 weeks

Collaborators and Investigators

• Sponsor: Biopolis S.L.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 2, 2020
• Primary Completion (Anticipated): February 2, 2021
• Study Completion (Anticipated): May 2, 2021

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Migraine; Probiotic
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: MIGR_PRO.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No