MigrainePromi2NCT02342262
The Effect of Probiotics on the Frequency and Intensity of Migraine Attacks and Intestinal Permeability
A study testing EcologicBarrier in people with Migraine, run by Wageningen University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- EcologicBarrier
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Oct 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects confirm to have migraine characterized by :
- Recurrent attacks of moderate to severe headaches, often one-sided and pounding, often with nausea and/or vomiting, aggravated by physical activity
- Sensitivity for light or sounds is possible but not exclusive.
- Attacks last for 4 to 72 hours.
- Self-reported frequency of migraine attacks (or days) at least 4 per month
- Fairly predictable/stable pattern of migraine attacks (frequency, duration, intensity)
- Age ≥ 18 years
- Good overall health (self-reported in medical questionnaire)
Who cannot join
- Migraine patients who suffer from chronic daily migraine/headaches
- Migraine patients who suffer from medication-dependent headaches
- Subjects who suffer from cluster headache or tension-type headaches
- Subjects who used antibiotics up to two months before the start of the study
- Subjects who are unwilling to stop taking probiotics other than study products
- Patients with a chronic use of non steroid anti inflammatory drugs (because of increased gut permeability)
- Patients with inflammatory bowel diseases (because of increased gut permeability)
- Pregnancy or lactation (because of their possible effect on migraine incidence)
About this study
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.
Read more
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.
- Conditions
- Migraine
- Being tested
- EcologicBarrier, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EcologicBarrierDietary supplement
multispecies probiotic product, 2x10-9 cfu/gram
PlaceboOther
similar appearance as the probiotic product, but without bacteria
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | EcologicBarrier, 5x10E9 cfu/day Receives: Dietary Supplement: EcologicBarrier |
| Placebo | Placebo comparator | carrier material of Ecologic Barrier, not containing bacterial strains Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of migraine attacks
Measured: 12 weeks
Secondary outcomes (2)
Intestinal permeability
Lactulose/mannitol in urine, zonulin in serum
Measured: 12 weeks
Inflammation markers.
pro-inflammatory cytokines in serum
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 posted19 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2015 (estimated)
- Study completionOct 2015 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole De Roos, PhD, Principal investigator, Wageningen UR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342262
- Sponsor's protocol ID
- NL46401.081.13
- Acronym
- Promi2
- Status last verified
- Jan 2015
- First submitted
- 9 Jan 2015
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Probiotics on the Frequency and Intensity of Migraine Attacks and Intestinal Permeability. A Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02342262
- Acronym / sponsor ID
- Promi2 / NL46401.081.13
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 19 Jan 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: EcologicBarrierEcologicBarrier, 5x10E9 cfu/day |
| Placebo | Placebo comparator | Other: Placebocarrier material of Ecologic Barrier, not containing bacterial strains |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects confirm to have migraine characterized by :
- Self-reported frequency of migraine attacks (or days) at least 4 per month
- Fairly predictable/stable pattern of migraine attacks (frequency, duration, intensity)
- Age ≥ 18 years
- Good overall health (self-reported in medical questionnaire)
Key exclusion criteria (8 listed)
- Migraine patients who suffer from chronic daily migraine/headaches
- Migraine patients who suffer from medication-dependent headaches
- Subjects who suffer from cluster headache or tension-type headaches
- Subjects who used antibiotics up to two months before the start of the study
- Subjects who are unwilling to stop taking probiotics other than study products
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 |
|---|---|---|
| EcologicBarriermultispecies probiotic product, 2x10-9 cfu/gram | Dietary supplement | Probiotics |
| Placebosimilar appearance as the probiotic product, but without bacteria | Other | Placebo |
Primary outcome
Frequency of migraine attacks
Time frame: 12 weeks
2 secondary outcomes
Intestinal permeability
Time frame: 12 weeks
Inflammation markers.
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 19 Jan 2015.
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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.
Nicole De Roos, PhD principal investigator
Wageningen UR
Questions about this trial
What is this clinical trial studying?
A study testing EcologicBarrier in people with Migraine, run by Wageningen University.
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 8 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 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of migraine attacks (time frame: 12 weeks). 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 19 Jan 2015.