To investigate whether probiotics can reduce incidence and severity of migraine attacks.
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence and severity of migraine attacks, measured by headache diaries
Secondary outcome
The disability due to migraine attacks is measured by validated headache
questionnaires (MIDAS and HDI questionnaire).
Background summary
Some theories suggest that migraine is caused by a *leaky gut*: an increased
intestinal permeability that allows undigested food particles to pass the
gastrointestinal wall. These components may cause migraine attacks. Probiotics
may be able to improve intestinal barrier function, and in this way, the
frequency and intensity of migraine attacks may reduce.
Study objective
To investigate whether probiotics can reduce incidence and severity of migraine
attacks.
Study design
Open label, linear study (before-after design).
Intervention
One dose per day of 2 g of Ecologic® Barrier (Winclove).
Study burden and risks
The probiotic mixture is available on the Dutch market for relief of
gastrointestinal complaints. The lactic acid bacteria in the mixture carry the
European Union Qualified Presumption of Safety (QPS). No side effects are
expected. No invasive measurements are performed. If patients benefit from the
treatment, this will increase their treatment options for migraine.
Bomenweg 2
6703HD Wageningen
NL
Bomenweg 2
6703HD Wageningen
NL
Listed location countries
Age
Inclusion criteria
- Frequency of at least 4 migraine attacks (or days) per month
- Pattern of migraine attacks predictable/stable (frequency, duration, intensity)
- Preferably: migraine patients with self-reported gastrointestinal complaints (before, during or after their migraine attacks), such as diarrhoea, bloating, or constipation.
Exclusion criteria
- chronic daily migraine
- medication-dependent headaches
- cluster headache or tension-type headaches
- antibiotics use up to two months before the start of the treatment period
- probiotics use up to two weeks before the start of the treatment period
- Female migraine patients who are pregnant or lactating (the migraine pattern is influenced).
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 | NL38763.081.11 |