MigraineMIGR_PRO2NCT04305522
Probiotics for the Prophylaxis of Migraine
A study testing Probiotic 1 and Probiotic 2 in people with Migraine, run by Biopolis S.L. at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Probiotic 1 and Probiotic 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesSpain
- Study dates
- 2 Mar 2020to 2 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 - 65 years.
- Signature of informed consent by the patient.
- Patients with confirmed migraine, diagnosed by a neurologist
- Patient-indicated frequency of migraine attacks (or days) of at least 4 per month.
- Fairly predictable and stable pattern of migraine attacks (frequency, duration, intensity)
Who cannot join
- Patients diagnosed with chronic migraine
- Migraine patients suffering from medication-dependent headaches.
- Patients suffering from cluster or tension-related headaches.
- Patients who used antibiotics up to two weeks before the start of the study.
- Patients who have taken other probiotics in the previous two months.
- Patients with chronic use of non-steroidal anti-inflammatory drugs.
- Patients with inflammatory bowel disease (due to increased intestinal permeability).
- Patients who are pregnant, breastfeeding or who do not commit to using an effective method of contraception during the course of the study.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario del Vinalopó
Elche, Alicante, 03293
Ana López García
Ana López García, Dr
Hospital Universitario de Torrevieja
Torrevieja, Alicante, 03186
Erika Maria Torres San Narciso
Erika Maria Torres San Narciso, Dr.
About this study
Official title: 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
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
- Migraine
- Being tested
- Probiotic 1, Placebo, Probiotic 2
- Keywords
- Probiotic, Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic 1Dietary supplement
Probiotic mixture with maltodextrin as a carrier.
PlaceboDietary supplement
Placebo comparator with maltodextrin as a carrier.
Probiotic 2Dietary supplement
Probiotic mixture with maltodextrin as a carrier.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic 1 group | Experimental | A commercially-available multi-strain probiotic with added magnesium and vitamin B6 Receives: Dietary Supplement: Probiotic 1 |
| Probiotic 2 group | Experimental | A multi-strain probiotic Receives: Dietary Supplement: Probiotic 2 |
| Placebo group | Placebo comparator | Identical placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days with migraine episodes
Number of days with migraine episodes in weeks 4
Measured: 4-week
Number of days with migraine episodes
Number of days with migraine episodes, in weeks 8
Measured: 8-week
Number of days with migraine episodes
Number of days with migraine episodes, in weeks 12.
Measured: 12-week
Secondary outcomes (12)
Number of migraine episodes
Number of migraine episodes, in weeks 4
Measured: 4 weeks
Number of migraine episodes
Number of migraine episodes, in weeks 8
Measured: 8 weeks
Number of migraine episodes
Number of migraine episodes, in weeks 12.
Measured: 12 weeks
Number of days that each patient requires the administration analgesia
Number of days that each patient requires the administration analgesia, in weeks 4
Measured: 4 weeks
Number of days that each patient requires the administration analgesia
Number of days that each patient requires the administration analgesia, in weeks 8
Measured: 8 weeks
Number of days that each patient requires the administration analgesia
Number of days that each patient requires the administration analgesia, in weeks 12
Measured: 12 weeks
Headache Impact Test (HIT-6) score
Headache Impact Test (HIT-6) score at weeks 0 and 4 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78)
Measured: 4 weeks
Headache Impact Test (HIT-6) score
Headache Impact Test (HIT-6) score at weeks 8 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78)
Measured: 8 weeks
Headache Impact Test (HIT-6) score
Headache Impact Test (HIT-6) score at weeks 12 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78)
Measured: 12 weeks
Treatment adherence rate
Treatment adherence rate using the returned capsules.
Measured: 12 weeks
Number of adverse events
Numbre od adverse effects reported
Measured: 12 weeks
Adherence to the treatment.
Percentage of treatment intake days.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start2 Mar 2020 (estimated)
- Primary completion2 Feb 2021 (estimated)
- Study completion2 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biopolis S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305522
- Sponsor's protocol ID
- MIGR_PRO.2
- Acronym
- MIGR_PRO2
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04305522
- Acronym / sponsor ID
- MIGR_PRO2 / MIGR_PRO.2
- Conditions
- Migraine
- Keywords
- Probiotic, Migraine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Biopolis S.L.Industry (pharma, biotech, devices)
- Study start
- 2 Mar 2020 (estimated)
- Primary completion
- 2 Feb 2021 (estimated)
- Study completion
- 2 May 2021 (estimated)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic 1 group | Experimental | Dietary Supplement: Probiotic 1A commercially-available multi-strain probiotic with added magnesium and vitamin B6 |
| Probiotic 2 group | Experimental | Dietary Supplement: Probiotic 2A multi-strain probiotic |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboIdentical placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 - 65 years.
- Signature of informed consent by the patient.
- Patients with confirmed migraine, diagnosed by a neurologist
- Patient-indicated frequency of migraine attacks (or days) of at least 4 per month.
- Fairly predictable and stable pattern of migraine attacks (frequency, duration, intensity)
Key exclusion criteria (8 listed)
- Patients diagnosed with chronic migraine
- Migraine patients suffering from medication-dependent headaches.
- Patients suffering from cluster or tension-related headaches.
- Patients who used antibiotics up to two weeks before the start of the study.
- Patients who have taken other probiotics in the previous two months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic 1Probiotic mixture with maltodextrin as a carrier. | Dietary supplement | Probiotic 1 group |
| PlaceboPlacebo comparator with maltodextrin as a carrier. | Dietary supplement | Placebo group |
| Probiotic 2Probiotic mixture with maltodextrin as a carrier. | Dietary supplement | Probiotic 2 group |
Primary outcome
Number of days with migraine episodes
Time frame: 4-week
Number of days with migraine episodes in weeks 4
Number of days with migraine episodes
Time frame: 8-week
Number of days with migraine episodes, in weeks 8
Number of days with migraine episodes
Time frame: 12-week
Number of days with migraine episodes, in weeks 12.
12 secondary outcomes
Number of migraine episodes
Time frame: 4 weeks
Number of migraine episodes
Time frame: 8 weeks
Number of migraine episodes
Time frame: 12 weeks
Number of days that each patient requires the administration analgesia
Time frame: 4 weeks
Number of days that each patient requires the administration analgesia
Time frame: 8 weeks
Number of days that each patient requires the administration analgesia
Time frame: 12 weeks
Headache Impact Test (HIT-6) score
Time frame: 4 weeks
Headache Impact Test (HIT-6) score
Time frame: 8 weeks
Headache Impact Test (HIT-6) score
Time frame: 12 weeks
Treatment adherence rate
Time frame: 12 weeks
Number of adverse events
Time frame: 12 weeks
Adherence to the treatment.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic 1 and Probiotic 2 in people with Migraine, run by Biopolis S.L. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Empar Chenoll, PhD (+34 673 53 53 44, maria.chenoll@adm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days with migraine episodes (time frame: 4-week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.