The Effect of Probiotics on the Frequency and Intensity of Migraine Attacks and Intestinal Permeability
NCT ID: NCT02342262
Last Updated: 2015-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2014-08-31
2015-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Probiotics
EcologicBarrier, 5x10E9 cfu/day
EcologicBarrier
multispecies probiotic product, 2x10-9 cfu/gram
Placebo
carrier material of Ecologic Barrier, not containing bacterial strains
Placebo
similar appearance as the probiotic product, but without bacteria
Interventions
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EcologicBarrier
multispecies probiotic product, 2x10-9 cfu/gram
Placebo
similar appearance as the probiotic product, but without bacteria
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Wageningen University
OTHER
Responsible Party
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Principal Investigators
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Nicole De Roos, PhD
Role: PRINCIPAL_INVESTIGATOR
Wageningen UR
Other Identifiers
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NL46401.081.13
Identifier Type: -
Identifier Source: org_study_id
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