The Effect of Probiotics on the Frequency and Intensity of Migraine Attacks and Intestinal Permeability

Not Applicable

• Conditions: Migraine
• Interventions: Dietary Supplement: EcologicBarrier; Other: Placebo

• Registration Number: NCT02342262
• Lead Sponsor: Wageningen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Status Verified: 2015-01
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-14
• Last Update Submitted: 2015-01-14
• Study First Posted: 2015-01-19
• Last Update Posted: 2015-01-19
• Primary Completion: 2015-08
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	EcologicBarrier	EcologicBarrier, 5x10E9 cfu/day
Placebo	Placebo	carrier material of Ecologic Barrier, not containing bacterial strains

Primary Outcome Measures

Name	Time	Method
Frequency of migraine attacks	12 weeks

Secondary Outcome Measures

Name	Time	Method
Inflammation markers.	12 weeks	pro-inflammatory cytokines in serum
Intestinal permeability	12 weeks	Lactulose/mannitol in urine, zonulin in serum