NCT04305522

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2021

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

March 3, 2020

Last Update Submit

March 11, 2020

Conditions

Migraine

Keywords

ProbioticMigraine

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (12)

  • Number of migraine episodes

    4 weeks

  • Number of migraine episodes

    8 weeks

  • Number of migraine episodes

    12 weeks

  • Number of days that each patient requires the administration analgesia

    4 weeks

  • Number of days that each patient requires the administration analgesia

    8 weeks

  • +7 more secondary outcomes

Study Arms (3)

Probiotic 1 group

EXPERIMENTAL

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

Dietary Supplement: Probiotic 1

Probiotic 2 group

EXPERIMENTAL

A multi-strain probiotic

Dietary Supplement: Probiotic 2

Placebo group

PLACEBO COMPARATOR

Identical placebo

Dietary Supplement: Placebo

Interventions

Probiotic 1DIETARY_SUPPLEMENT

Probiotic mixture with maltodextrin as a carrier.

Probiotic 1 group
PlaceboDIETARY_SUPPLEMENT

Placebo comparator with maltodextrin as a carrier.

Placebo group
Probiotic 2DIETARY_SUPPLEMENT

Probiotic mixture with maltodextrin as a carrier.

Probiotic 2 group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario del Vinalopó

Elche, Alicante, 03293, Spain

Location

Hospital Universitario de Torrevieja

Torrevieja, Alicante, 03186, Spain

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

María Empar Chenoll, PhD

CONTACT

+34 673 53 53 44maria.chenoll@adm.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 12, 2020

Study Start

March 2, 2020

Primary Completion

February 2, 2021

Study Completion

May 2, 2021

Last Updated

March 12, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)