Pediatric MigraineNCT07092241
The Efficacy of Beneficial Intestinal Microbiota in the Treatment of Migraine and Its Mechanism: Basic and Clinical Studies
A study testing microbiota in people with Pediatric Migraine, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
pediatric migraine Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Pediatric Migraine
- What is being tested?
- microbiota
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinical diagnosis with migraine
Who cannot join
- Receiving antibiotic treatment for the past 2 weeks
- Receiving probiotic treatment for the past one month
- Multiple congenital anomalies, for instance, meningoencephalocele, chromosomal anomalies, and congenital intestinal atresia, etc.
- Mental retardation that is difficult to describe the symptoms
Trial locations and contacts
1 site in 1 country.
About this study
pediatric migraine
Read the detailed description
To explore the efficacy and pathogenesis of gut-brain axis by basic and clinical approach, The investigators will apply the candidate beneficial bacteria selected from the results of our previous clinical studies to the migraine animal model and will further conduct a clinical trial that investigates the efficacy of the commercial probiotics containing these candidate beneficial bacteria for the pediatric migraineurs to explore their therapeutic potential in treating migraine. The participants will keep headache diary and disability assessment by Pediatric Migraine Disability Assessment Score (PedMIDAS: 0-240) will be evaluated before and at the end of 12 weeks therapy. The investigators will also examine the effects of the protective bacteria clinically by measuring CGRP, a key biomarker of migraine, and proinflammatory cytokines before and after treatment by clinical approach, and explore these important markers on both the gut and brain ends in the migraine animal model to clarify the mechanism of gut-brain axis in migraine pathogenesis.
- Conditions
- Pediatric Migraine
- Being tested
- microbiota
- Keywords
- pediatric migraine, gut-brain-axis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microbiotaDietary supplement
Bifidobacterium breve and Bifidobacterium longum
microbiotaDietary supplement
Bifidobacterium and Lactobacillus
| Study group | Role | What they receive |
|---|---|---|
| The placebo group | Placebo comparator | Double set parallel Receives: Dietary Supplement: microbiota |
| treated group | Active comparator | Not described Receives: Dietary Supplement: microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of beneficial intestinal microbiota in the treatment of migraine and its mechanism: basic and clinical studies
evaluation of the efficacy: headache intensity (pain score: 0-10), frequency (headache times per week) and headache days per week as well as disability assessment by Pediatric Migraine Disability Assessment Score (PedMIDAS: 0-240). The listed outcome measures are all distinct clinical assessments related to migraine burden and are not derived from or dependent on variables such as weight or height. Each outcome is measured using its own standardized scale or unit and will be reported separately as specified in the protocol.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Jan 2023
- Primary completion20 Mar 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric MigraineStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Model description
- Double set parallel
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092241
- Sponsor's protocol ID
- 202207086RIND
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared due to privacy concerns and the lack of participant consent for public data sharing. Additionally, the scope of the study does not include provisions for data sharing beyond the primary analyses.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Beneficial Intestinal Microbiota in the Treatment of Migraine and Its Mechanism: Basic and Clinical Studies
- ClinicalTrials.gov ID
- NCT07092241
- Acronym / sponsor ID
- 202207086RIND
- Conditions
- Pediatric Migraine
- Keywords
- pediatric migraine, gut-brain-axis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jul 2025 (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.
pediatric migraine
Detailed description
To explore the efficacy and pathogenesis of gut-brain axis by basic and clinical approach, The investigators will apply the candidate beneficial bacteria selected from the results of our previous clinical studies to the migraine animal model and will further conduct a clinical trial that investigates the efficacy of the commercial probiotics containing these candidate beneficial bacteria for the pediatric migraineurs to explore their therapeutic potential in treating migraine. The participants will keep headache diary and disability assessment by Pediatric Migraine Disability Assessment Score (PedMIDAS: 0-240) will be evaluated before and at the end of 12 weeks therapy. The investigators will also examine the effects of the protective bacteria clinically by measuring CGRP, a key biomarker of migraine, and proinflammatory cytokines before and after treatment by clinical approach, and explore these important markers on both the gut and brain ends in the migraine animal model to clarify the mechanism of gut-brain axis in migraine pathogenesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Double set parallel
| Arm | Type | Receives |
|---|---|---|
| The placebo group | Placebo comparator | Dietary Supplement: microbiotaDouble set parallel |
| treated group | Active comparator | Dietary Supplement: microbiota |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- clinical diagnosis with migraine
Key exclusion criteria (4 listed)
- Receiving antibiotic treatment for the past 2 weeks
- Receiving probiotic treatment for the past one month
- Multiple congenital anomalies, for instance, meningoencephalocele, chromosomal anomalies, and congenital intestinal atresia, etc.
- Mental retardation that is difficult to describe the symptoms
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 |
|---|---|---|
| microbiotaBifidobacterium breve and Bifidobacterium longum | Dietary supplement | The placebo group, treated group |
| microbiotaBifidobacterium and Lactobacillus | Dietary supplement | The placebo group |
Primary outcome
The efficacy of beneficial intestinal microbiota in the treatment of migraine and its mechanism: basic and clinical studies
Time frame: From enrollment to the end of treatment at 12 weeks
evaluation of the efficacy: headache intensity (pain score: 0-10), frequency (headache times per week) and headache days per week as well as disability assessment by Pediatric Migraine Disability Assessment Score (PedMIDAS: 0-240). The listed outcome measures are all distinct clinical assessments related to migraine burden and are not derived from or dependent on variables such as weight or height. Each outcome is measured using its own standardized scale or unit and will be reported separately as specified in the protocol.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No. The data will not be shared due to privacy concerns and the lack of participant consent for public data sharing. Additionally, the scope of the study does not include provisions for data sharing beyond the primary analyses.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microbiota in people with Pediatric Migraine, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
The efficacy of beneficial intestinal microbiota in the treatment of migraine and its mechanism: basic and clinical studies (time frame: From enrollment to the end of treatment at 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 29 Jul 2025.