To test whether probiotics, as adjuvant therapy, can reduce incidence and severity of migraine attacks by reducing intestinal permeability.
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of migraine (measured by diaries, number of days with migraine in 4
weeks)
Secondary outcome
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. Further, 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.
Background summary
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.
Study 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.
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).
Study burden and risks
The lactic acid bacteria in the mixture carry the European Union Qualified
Presumption of Safety (QPS). No side effects are expected. The probiotic
mixture is available on the Dutch market for relief of gastrointestinal
complaints. The product has been used before in the ProMi study with migraine
patients, with no adverse effects. Invasive measurements are restricted to
blood sampling; collection of urine and feces may be considered unpleasant. If
patients benefit from the probiotic intervention, this will help their
management of migraine.
Bomenweg 2
Wageningen 6703HD
NL
Bomenweg 2
Wageningen 6703HD
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46401.081.13 |