Trials / Unknown
UnknownNCT04305522
Probiotics for the Prophylaxis of Migraine
A Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Two Probiotic Interventions For The Prophylaxis of Migraine in Patients Diagnosed With Episodic Migraine
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- Biopolis S.L. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to understand the efficacy of two probiotic interventions as prophylaxes of migraine symptoms in individuals diagnosed with episodic migraine. The primary outcome measure will be migraine days per month, but secondary outcome measures such as use of analgesia, the wider impact of migraine (as assessed through the HIT-6 score) will also be assessed. Finally adverse effects will be evaluated. The study will have three arms: two arms including the two different probiotic preparations and a third placebo arm.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Probiotic 1 | Probiotic mixture with maltodextrin as a carrier. |
| DIETARY_SUPPLEMENT | Placebo | Placebo comparator with maltodextrin as a carrier. |
| DIETARY_SUPPLEMENT | Probiotic 2 | Probiotic mixture with maltodextrin as a carrier. |
Timeline
- Start date
- 2020-03-02
- Primary completion
- 2021-02-02
- Completion
- 2021-05-02
- First posted
- 2020-03-12
- Last updated
- 2020-03-12
Locations
2 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT04305522. Inclusion in this directory is not an endorsement.