Clinical trial NCT02342262: The Effect of Probiotics on the Frequency and Intensity of Migraine Attacks and Intestinal Permeability
Official title: The Effects of Probiotics on the Frequency and Intensity of Migraine Attacks and Intestinal Permeability. A Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Frequency of migraine attacks
timeFrame: 12 weeks
Secondary outcomes:
measure: Intestinal permeability
timeFrame: 12 weeks
measure: Inflammation markers.
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Wageningen UR
name: Nicole De Roos, PhD
role: PRINCIPAL_INVESTIGATOR
References: