Migraine Clinical Trial
Official title:
The Effects of Probiotics on the Frequency and Intensity of Migraine Attacks and Intestinal Permeability. A Placebo-controlled Trial
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06192173 -
Patent Foramen Ovale Closure in Migraine
|
||
| Completed |
NCT05525611 -
Cabergoline as a Preventive Treatment for Chronic Migraine
|
N/A | |
| Recruiting |
NCT03832998 -
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
|
Phase 3 | |
| Enrolling by invitation |
NCT04196933 -
Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma
|
N/A | |
| Completed |
NCT06304675 -
Manageable Environmental Factors in Migraine
|
||
| Completed |
NCT04084314 -
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
|
Phase 4 | |
| Recruiting |
NCT05517200 -
Pilot Study for a Machine Learning Test for Migraine
|
||
| Completed |
NCT04179474 -
Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
|
Phase 1 | |
| Recruiting |
NCT04603976 -
Registry for Migraine - Clinical Core
|
Phase 4 | |
| Completed |
NCT03597529 -
CHOCOlate MeLatonin for AdolescenT MigrainE
|
Phase 2 | |
| Completed |
NCT04197349 -
Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman
|
Phase 1 | |
| Recruiting |
NCT05891808 -
miR-155 Expression in Episodic and Chronic Migraine
|
||
| Active, not recruiting |
NCT05064371 -
Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan
|
Phase 3 | |
| Suspended |
NCT04069572 -
Vibratory Stimulation for the Treatment of Chronic Pain
|
N/A | |
| Not yet recruiting |
NCT04859374 -
Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach
|
N/A | |
| Not yet recruiting |
NCT03083860 -
Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
|
N/A | |
| Completed |
NCT02905227 -
A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder
|
Phase 1 | |
| Enrolling by invitation |
NCT02532023 -
The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients
|
Phase 4 | |
| Completed |
NCT02108678 -
One-Day Intervention for Depression and Impairment in Migraine Patients
|
N/A | |
| Completed |
NCT01741246 -
Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging
|
N/A |