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Probiotics for the Prophylaxis of Migraine (MIGR_PRO2)

Primary Purpose

Migraine

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Probiotic 1
Placebo
Probiotic 2
Sponsored by
Biopolis S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Probiotic, Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario del Vinalopó
  • Hospital Universitario de Torrevieja

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Probiotic 1 group

Probiotic 2 group

Placebo group

Arm Description

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

A multi-strain probiotic

Identical placebo

Outcomes

Primary Outcome Measures

Number of days with migraine episodes
Number of days with migraine episodes in weeks 4
Number of days with migraine episodes
Number of days with migraine episodes, in weeks 8
Number of days with migraine episodes
Number of days with migraine episodes, in weeks 12.

Secondary Outcome Measures

Number of migraine episodes
Number of migraine episodes, in weeks 4
Number of migraine episodes
Number of migraine episodes, in weeks 8
Number of migraine episodes
Number of migraine episodes, in weeks 12.
Number of days that each patient requires the administration analgesia
Number of days that each patient requires the administration analgesia, in weeks 4
Number of days that each patient requires the administration analgesia
Number of days that each patient requires the administration analgesia, in weeks 8
Number of days that each patient requires the administration analgesia
Number of days that each patient requires the administration analgesia, in weeks 12
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)
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)
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)
Treatment adherence rate
Treatment adherence rate using the returned capsules.
Number of adverse events
Numbre od adverse effects reported
Adherence to the treatment.
Percentage of treatment intake days.

Full Information

First Posted
March 3, 2020
Last Updated
March 11, 2020
Sponsor
Biopolis S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT04305522
Brief Title
Probiotics for the Prophylaxis of Migraine
Acronym
MIGR_PRO2
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2020 (Anticipated)
Primary Completion Date
February 2, 2021 (Anticipated)
Study Completion Date
May 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biopolis S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Probiotic, Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic 1 group
Arm Type
Experimental
Arm Description
A commercially-available multi-strain probiotic with added magnesium and vitamin B6
Arm Title
Probiotic 2 group
Arm Type
Experimental
Arm Description
A multi-strain probiotic
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Identical placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic 1
Intervention Description
Probiotic mixture with maltodextrin as a carrier.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator with maltodextrin as a carrier.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic 2
Intervention Description
Probiotic mixture with maltodextrin as a carrier.
Primary Outcome Measure Information:
Title
Number of days with migraine episodes
Description
Number of days with migraine episodes in weeks 4
Time Frame
4-week
Title
Number of days with migraine episodes
Description
Number of days with migraine episodes, in weeks 8
Time Frame
8-week
Title
Number of days with migraine episodes
Description
Number of days with migraine episodes, in weeks 12.
Time Frame
12-week
Secondary Outcome Measure Information:
Title
Number of migraine episodes
Description
Number of migraine episodes, in weeks 4
Time Frame
4 weeks
Title
Number of migraine episodes
Description
Number of migraine episodes, in weeks 8
Time Frame
8 weeks
Title
Number of migraine episodes
Description
Number of migraine episodes, in weeks 12.
Time Frame
12 weeks
Title
Number of days that each patient requires the administration analgesia
Description
Number of days that each patient requires the administration analgesia, in weeks 4
Time Frame
4 weeks
Title
Number of days that each patient requires the administration analgesia
Description
Number of days that each patient requires the administration analgesia, in weeks 8
Time Frame
8 weeks
Title
Number of days that each patient requires the administration analgesia
Description
Number of days that each patient requires the administration analgesia, in weeks 12
Time Frame
12 weeks
Title
Headache Impact Test (HIT-6) score
Description
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)
Time Frame
4 weeks
Title
Headache Impact Test (HIT-6) score
Description
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)
Time Frame
8 weeks
Title
Headache Impact Test (HIT-6) score
Description
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)
Time Frame
12 weeks
Title
Treatment adherence rate
Description
Treatment adherence rate using the returned capsules.
Time Frame
12 weeks
Title
Number of adverse events
Description
Numbre od adverse effects reported
Time Frame
12 weeks
Title
Adherence to the treatment.
Description
Percentage of treatment intake days.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Empar Chenoll, PhD
Phone
+34 673 53 53 44
Email
maria.chenoll@adm.com
Facility Information:
Facility Name
Hospital Universitario del Vinalopó
City
Elche
State/Province
Alicante
ZIP/Postal Code
03293
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana López García
First Name & Middle Initial & Last Name & Degree
Ana López García, Dr
Facility Name
Hospital Universitario de Torrevieja
City
Torrevieja
State/Province
Alicante
ZIP/Postal Code
03186
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Maria Torres San Narciso
First Name & Middle Initial & Last Name & Degree
Erika Maria Torres San Narciso, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

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Probiotics for the Prophylaxis of Migraine

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