Probiotic effects in migraine
Phase 3
Recruiting
- Conditions
- Condition 1: Migraine. Condition 2: IBS.MigraineIrritable bowel syndrome
- Registration Number
- IRCT20101209005352N5
- Lead Sponsor
- Zanjan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
Confirmed migraine by ICHD3 criteria
Confirmed IBS by Rome IV criteria
Exclusion Criteria
Affliction to gastrointestinal diseases other than IBS
Affliction to neurologic diseases or headaches other than migraine
Patients not referring to clinic after first visit
IBS-D patients with contraindication to TCA
IBS-C patients with contraindication to SNRI
IBS patients not classified as IBS-C or IBS-D
Consumption of antibiotics of any kind during study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Migraine severity. Timepoint: Severity of migraine is measured at day 0 and 90 of the trial. Method of measurement: Migraine severity is evaluated by Visual Analogue Scale.;Migraine frequency. Timepoint: Weekly. Method of measurement: Episodes of headache per week.;IBS severity. Timepoint: Severity of IBS is measured at day 0 and 90 of the trial. Method of measurement: Visual Analogue Scale from 1 to 10.;Number of analgesics consumed per week. Timepoint: Weekly. Method of measurement: Number of analgesics.;Aura. Timepoint: Migraine aura is determined at the first visit. Method of measurement: Presence or absence of aura.
- Secondary Outcome Measures
Name Time Method