The Effect of Probiotics on the Frequency and Intensity of Migraine Attacks and Intestinal Permeability (Promi2)

Wageningen University

Status

Unknown

Conditions

Migraine

Treatments

Dietary Supplement: EcologicBarrier

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02342262

NL46401.081.13

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)