NCT02342262

Brief Summary

RATIONALE: The prevalence of migraine is higher in patients with various intestinal diseases. An explanation could be that migraine is caused by a 'leaky gut': an increased intestinal permeability that allows food particles to pass the gastrointestinal wall. Probiotics may be able to improve intestinal barrier function. OBJECTIVE: To test whether probiotics, as adjuvant therapy, can reduce incidence and severity of migraine attacks by reducing intestinal permeability. STUDY DESIGN: 12-week placebo-controlled randomized double-blind intervention with selected probiotics. STUDY POPULATION: Adults who experience at least 4 migraine attacks per month. INTERVENTION: Subjects will receive either one daily dose of 2 g of Ecologic® Barrier or 2 grams of the placebo, containing only the carrier material (both provided by Winclove Probiotics). MAIN STUDY PARAMETERS/ENDPOINTS: Incidence and severity of migraine attacks, measured by diaries and validated headache questionnaires will be measured at baseline and after 4, 8, and 12 weeks of probiotic/placebo administration. Secondary, intestinal permeability will be measured by the lactulose/mannitol absorption test in urine (screening, baseline and 12 weeks) and by fecal zonulin (baseline, 4, 8, and 12 weeks). Inflammation will be assessed from blood C-reactive protein and cytokine concentrations (baseline, 4, 8, and 12 weeks). Fecal samples will also be used for microbial analysis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

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

August 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

January 9, 2015

Last Update Submit

January 14, 2015

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • Frequency of migraine attacks

    12 weeks

Secondary Outcomes (2)

  • Intestinal permeability

    12 weeks

  • Inflammation markers.

    12 weeks

Study Arms (2)

Probiotics

EXPERIMENTAL

EcologicBarrier, 5x10E9 cfu/day

Dietary Supplement: EcologicBarrier

Placebo

PLACEBO COMPARATOR

carrier material of Ecologic Barrier, not containing bacterial strains

Other: Placebo

Interventions

EcologicBarrierDIETARY_SUPPLEMENT

multispecies probiotic product, 2x10-9 cfu/gram

Probiotics
PlaceboOTHER

similar appearance as the probiotic product, but without bacteria

Placebo

Eligibility Criteria

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

You may qualify if:

  • Subjects confirm to have migraine characterized by :
  • Recurrent attacks of moderate to severe headaches, often one-sided and pounding, often with nausea and/or vomiting, aggravated by physical activity
  • Sensitivity for light or sounds is possible but not exclusive.
  • Attacks last for 4 to 72 hours.
  • Self-reported frequency of migraine attacks (or days) at least 4 per month
  • Fairly predictable/stable pattern of migraine attacks (frequency, duration, intensity)
  • Age ≥ 18 years
  • Good overall health (self-reported in medical questionnaire)

You may not qualify if:

  • Migraine patients who suffer from chronic daily migraine/headaches
  • Migraine patients who suffer from medication-dependent headaches
  • Subjects who suffer from cluster headache or tension-type headaches
  • Subjects who used antibiotics up to two months before the start of the study
  • Subjects who are unwilling to stop taking probiotics other than study products
  • Patients with a chronic use of non steroid anti inflammatory drugs (because of increased gut permeability)
  • Patients with inflammatory bowel diseases (because of increased gut permeability)
  • Pregnancy or lactation (because of their possible effect on migraine incidence)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Nicole De Roos, PhD

    Wageningen UR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 19, 2015

Study Start

August 1, 2014

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

January 19, 2015

Record last verified: 2015-01