THE EFFECT OF PROBIOTICS ON THE FREQUENCY AND INTENSITY OF MIGRAINE ATTACKS AND INTESTINAL PERMEABILITY - A PLACEBO-CONTROLLED TRIA

Completed

Conditions: migraine
unilateral headache
10018012
10019231

Registration Number: NL-OMON38953

Lead Sponsor: Wageningen Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

Subjects confirm to have migraine characterized by :
o Recurrent attacks of moderate to severe headaches, often one-sided and pounding, often with nausea and/or vomiting, aggravated by physical activity
o Sensitivity for light or sounds is possible but not exclusive.
o 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
- General good health

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
- Pregnancy or lactation (because of their possible effect on migraine incidence
- Patients who are unwilling to stop current use of probiotics
- Patients who have a chronic use of NSAIDs
- patients with inflammatory bowel diseases

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of migraine (measured by diaries, number of days with migraine in 4<br /><br>weeks)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Severity of migraine attacks, measured by diaries and validated headache<br /><br>questionnaires will be measured at baseline and after 4, 8, and 12 weeks of<br /><br>probiotic/placebo administration. Further, intestinal permeability will be<br /><br>measured by the lactulose/mannitol absorption test in urine (screening,<br /><br>baseline and 12 weeks) and by fecal zonulin (baseline, 4, 8, and 12 weeks).<br /><br>Inflammation will be assessed from blood C-reactive protein and cytokine<br /><br>concentrations (baseline, 4, 8, and 12 weeks). Fecal samples will also be used<br /><br>for microbial analysis. </p><br>