Migraine in ChildrenNCT05969990
Tryptophan Metabolites in Pediatric Migraine
An observational study of Migraine in Children, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Background: Migraine is a common neurological disorder that also has a significant prevalence in children. Although the exact etiology of migraine is unknown, recent studies suggest an association between intestinal flora and migraine, and tryptophan metabolism is an important link between intestinal flora and the… Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine in Children
- What is being tested?
- tryptophan metabolites in plasma
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Observational
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 100 children with migraine and 100 healthy children
Who may be able to join
- Age 4-18 years, male or female.
- Meet the ICHD-3 diagnostic criteria for migraine with aura, without aura, and chronic migraine.
- Migraine is diagnosed by two or more specialized neurologists.
- PedMIDAS score was more than 11.
- Migraine was never treated.
- Patients and family members gave informed consent to the study's purpose, significance, risks, benefits, and information of the study.
Who cannot join
- Presence of drug overdose.
- Autoimmune diseases.
- Neurological disorders other than migraine, intracranial masses.
- Congenital or genetic disorders.
- Diabetes, bronchial asthma, cardiovascular disease, pulmonary disease.
- Other types of primary and secondary headaches.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Junhui Liu
Jinan, 250012
Junhui Liu, 15064039296, 15064039296@163.com
About this study
Official title: Exploration of the Role of Tryptophan Metabolites in Pediatric Migraine
Background:
Migraine is a common neurological disorder that also has a significant prevalence in children. Although the exact etiology of migraine is unknown, recent studies suggest an association between intestinal flora and migraine, and tryptophan metabolism is an important link between intestinal flora and the nervous system. However, the role of tryptophan metabolites in childhood migraine is not fully understood. Therefore, the aim of this study was to investigate the specific role of tryptophan metabolites in childhood migraine.
Read more
Study objectives:
The main objectives of this study were to assess the changes in tryptophan metabolites in childhood migraine and to explore their relationship with migraine attacks. Specific objectives include:
- to determine the differences in tryptophan metabolites between children with migraine and healthy children;
- to explore the correlation between tryptophan metabolites and migraine attacks
- to assess the potential mechanisms of the role of tryptophan metabolites in childhood migraine.
Study methods:
- participant recruitment: a certain number of pediatric migraine patients and healthy children were recruited as controls.
- data collection: clinical information, medical history, and blood samples were collected from participants.
- Tryptophan metabolite analysis: using appropriate experimental techniques, ELISA
Statistical analysis:
The main analyses included the following:
- comparison of differences in tryptophan metabolites between migraine and control groups, using t-test or Wilcoxon rank sum test.
- To assess the value of tryptophan metabolites in the diagnosis of migraine, ROC curve analysis was used to calculate the sensitivity, specificity, and AUC.
- To explore the factors associated with tryptophan metabolites and migraine, multiple logistic regression analysis was used to assess the risk and protective effects of each factor on migraine.
Experimental hypothesis:
Our experimental hypothesis was that tryptophan metabolites may play a key role in the pathogenesis of childhood migraine, particularly kynurenine (KYN), quinolinic acid (QUINA), and kynurenic acid (KYNA). We hypothesized that in pediatric migraine patients, the concentrations of tryptophan metabolites would change significantly compared to healthy children. We further hypothesized that the concentrations of certain tryptophan metabolites correlate with the frequency and severity of migraine attacks. Based on these hypotheses, our study will examine tryptophan metabolite concentrations in blood samples and perform a comparative analysis between pediatric migraineurs and healthy children. We will also explore the correlation between tryptophan metabolites and migraine attacks and determine their risk and protective role in childhood migraine through multiple logistic regression analysis.
Outlook:
The results of this study are expected to reveal the important role of tryptophan metabolites in the pathogenesis of migraine in children and provide a new basis for the diagnosis and treatment of migraine in children. In addition, the study may also provide theoretical support for the development of relevant therapeutic strategies and interventions, and provide new ideas for the prevention and management of migraine in children.
Read the detailed description
Method for determination of tryptophan metabolite content:
- Timing of blood collection In the case group, blood was collected at any time during the first 2-4 hours of the migraine attack; in the inter-migraine attack group, blood was collected at least 24 hours before and after the headache-free period. In the healthy control group, blood was collected in a quiet state.
- Storage and testing methods 5 ml of elbow venous blood was collected from patients and healthy children in purple tubes, and the samples were immediately transferred to ice-cold glass tubes containing a mixture of anticoagulant and protease inhibitor, and centrifuged at 3000 rpm for 5 minutes at 4°C. The supernatant was stored at -80°C, and tryptophan metabolite levels were measured by ELISA, and the case and control groups were compared and analyzed.
Feasibility analysis
- The Elisa kit technology and medical statistics technology used in this project have been widely and maturely applied in other biomedical research fields, and the project has all the core technology reserves that can ensure the successful completion of the project.
- The PICU of Qilu Hospital of Shandong University, which has rich experience in scientific research and clinical medicine, as well as rich clinical cases, is sufficient to meet the needs of scientific research; we have sufficient strength in terms of scientific research strength, talent demand and economic support to ensure the successful completion of our experiment.
- The pediatric outpatient clinic of Qilu Hospital of Shandong University receives a large number of children with migraine every day, and the severity of the disease is complex and varied, so the number and diversity of children with migraine are sufficient to meet the needs of our experiment.
- Conditions
- Migraine in Children
- Being tested
- tryptophan metabolites in plasma
- Keywords
- Migraine in Children, tryptophan metabolites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tryptophan metabolites in plasmaOther
we will investigate the tryptophan metabolites in plasma of children with migraine
| Study group | Role | What they receive |
|---|---|---|
| case group | 100 children with migraine are included into case group and we will collect the blood of them to investigate tryptophan metabolites plasma concentration Receives: Other: tryptophan metabolites in plasma | |
| control group | 100 healthy children are included into control group and we will collect the blood of them to investigate tryptophan metabolites plasma concentration Receives: Other: tryptophan metabolites in plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tryptophan
Measured: In ictal period, during the first 2-4 hours of the attack. In interictal period, blood was collected at least 24 hours before and after the headache-free period. In the healthy group, blood was collected in the morning after fasting for eight hours.
Kynurenine
Measured: In ictal period, during the first 2-4 hours of the attack. In interictal period, blood was collected at least 24 hours before and after the headache-free period. In the healthy group, blood was collected in the morning after fasting for eight hours.
Kynurenic acid
Measured: In ictal period, during the first 2-4 hours of the attack. In interictal period, blood was collected at least 24 hours before and after the headache-free period. In the healthy group, blood was collected in the morning after fasting for eight hours.
Quinolinic acid
Measured: In ictal period, during the first 2-4 hours of the attack. In interictal period, blood was collected at least 24 hours before and after the headache-free period. In the healthy group, blood was collected in the morning after fasting for eight hours.
Serotonin
Measured: In ictal period, during the first 2-4 hours of the attack. In interictal period, blood was collected at least 24 hours before and after the headache-free period. In the healthy group, blood was collected in the morning after fasting for eight hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Migraine in ChildrenStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinjie Liu, Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969990
- Sponsor's protocol ID
- QLCR20210182
- Status last verified
- Jan 2023
- First submitted
- 15 May 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kortesi T, Spekker E, Vecsei L. Exploring the Tryptophan Metabolic Pathways in Migraine-Related Mechanisms. Cells. 2022 Nov 27;11(23):3795. doi: 10.3390/cells11233795.
PubMed 36497053Curto M, Lionetto L, Negro A, Capi M, Perugino F, Fazio F, Giamberardino MA, Simmaco M, Nicoletti F, Martelletti P. Altered serum levels of kynurenine metabolites in patients affected by cluster headache. J Headache Pain. 2015;17(1):27. doi: 10.1186/s10194-016-0620-2. Epub 2016 Mar 22.
PubMed 27000870Liu J, Xi K, Zhang L, Han M, Wang Q, Liu X. Tryptophan metabolites and gut microbiota play an important role in pediatric migraine diagnosis. J Headache Pain. 2024 Jan 5;25(1):2. doi: 10.1186/s10194-023-01708-9.
PubMed 38177986
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Role of Tryptophan Metabolites in Pediatric Migraine
- ClinicalTrials.gov ID
- NCT05969990
- Acronym / sponsor ID
- QLCR20210182
- Conditions
- Migraine in Children
- Keywords
- Migraine in Children, tryptophan metabolites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Aug 2023 (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.
Background:
Migraine is a common neurological disorder that also has a significant prevalence in children. Although the exact etiology of migraine is unknown, recent studies suggest an association between intestinal flora and migraine, and tryptophan metabolism is an important link between intestinal flora and the nervous system. However, the role of tryptophan metabolites in childhood migraine is not fully understood. Therefore, the aim of this study was to investigate the specific role of tryptophan metabolites in childhood migraine.
Study objectives:
The main objectives of this study were to assess the changes in tryptophan metabolites in childhood migraine and to explore their relationship with migraine attacks. Specific objectives include:
- to determine the differences in tryptophan metabolites between children with migraine and healthy children;
- to explore the correlation between tryptophan metabolites and migraine attacks
- to assess the potential mechanisms of the role of tryptophan metabolites in childhood migraine.
Study methods:
- participant recruitment: a certain number of pediatric migraine patients and healthy children were recruited as controls.
- data collection: clinical information, medical history, and blood samples were collected from participants.
- Tryptophan metabolite analysis: using appropriate experimental techniques, ELISA
Statistical analysis:
The main analyses included the following:
- comparison of differences in tryptophan metabolites between migraine and control groups, using t-test or Wilcoxon rank sum test.
- To assess the value of tryptophan metabolites in the diagnosis of migraine, ROC curve analysis was used to calculate the sensitivity, specificity, and AUC.
- To explore the factors associated with tryptophan metabolites and migraine, multiple logistic regression analysis was used to assess the risk and protective effects of each factor on migraine.
Experimental hypothesis:
Our experimental hypothesis was that tryptophan metabolites may play a key role in the pathogenesis of childhood migraine, particularly kynurenine (KYN), quinolinic acid (QUINA), and kynurenic acid (KYNA). We hypothesized that in pediatric migraine patients, the concentrations of tryptophan metabolites would change significantly compared to healthy children. We further hypothesized that the concentrations of certain tryptophan metabolites correlate with the frequency and severity of migraine attacks. Based on these hypotheses, our study will examine tryptophan metabolite concentrations in blood samples and perform a comparative analysis between pediatric migraineurs and healthy children. We will also explore the correlation between tryptophan metabolites and migraine attacks and determine their risk and protective role in childhood migraine through multiple logistic regression analysis.
Outlook:
The results of this study are expected to reveal the important role of tryptophan metabolites in the pathogenesis of migraine in children and provide a new basis for the diagnosis and treatment of migraine in children. In addition, the study may also provide theoretical support for the development of relevant therapeutic strategies and interventions, and provide new ideas for the prevention and management of migraine in children.
Detailed description
Method for determination of tryptophan metabolite content:
- Timing of blood collection In the case group, blood was collected at any time during the first 2-4 hours of the migraine attack; in the inter-migraine attack group, blood was collected at least 24 hours before and after the headache-free period. In the healthy control group, blood was collected in a quiet state.
- Storage and testing methods 5 ml of elbow venous blood was collected from patients and healthy children in purple tubes, and the samples were immediately transferred to ice-cold glass tubes containing a mixture of anticoagulant and protease inhibitor, and centrifuged at 3000 rpm for 5 minutes at 4°C. The supernatant was stored at -80°C, and tryptophan metabolite levels were measured by ELISA, and the case and control groups were compared and analyzed.
Feasibility analysis
- The Elisa kit technology and medical statistics technology used in this project have been widely and maturely applied in other biomedical research fields, and the project has all the core technology reserves that can ensure the successful completion of the project.
- The PICU of Qilu Hospital of Shandong University, which has rich experience in scientific research and clinical medicine, as well as rich clinical cases, is sufficient to meet the needs of scientific research; we have sufficient strength in terms of scientific research strength, talent demand and economic support to ensure the successful completion of our experiment.
- The pediatric outpatient clinic of Qilu Hospital of Shandong University receives a large number of children with migraine every day, and the severity of the disease is complex and varied, so the number and diversity of children with migraine are sufficient to meet the needs of our experiment.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Other: tryptophan metabolites in plasma100 children with migraine are included into case group and we will collect the blood of them to investigate tryptophan metabolites plasma concentration |
| control group | – | Other: tryptophan metabolites in plasma100 healthy children are included into control group and we will collect the blood of them to investigate tryptophan metabolites plasma concentration |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 100 children with migraine and 100 healthy children
Key inclusion criteria (6 listed)
- Age 4-18 years, male or female.
- Meet the ICHD-3 diagnostic criteria for migraine with aura, without aura, and chronic migraine.
- Migraine is diagnosed by two or more specialized neurologists.
- PedMIDAS score was more than 11.
- Migraine was never treated.
Key exclusion criteria (6 listed)
- Presence of drug overdose.
- Autoimmune diseases.
- Neurological disorders other than migraine, intracranial masses.
- Congenital or genetic disorders.
- Diabetes, bronchial asthma, cardiovascular disease, pulmonary disease.
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 |
|---|---|---|
| tryptophan metabolites in plasmawe will investigate the tryptophan metabolites in plasma of children with migraine | Other | case group, control group |
Primary outcome
Tryptophan
Time frame: In ictal period, during the first 2-4 hours of the attack. In interictal period, blood was collected at least 24 hours before and after the headache-free period. In the healthy group, blood was collected in the morning after fasting for eight hours.
Kynurenine
Time frame: In ictal period, during the first 2-4 hours of the attack. In interictal period, blood was collected at least 24 hours before and after the headache-free period. In the healthy group, blood was collected in the morning after fasting for eight hours.
Kynurenic acid
Time frame: In ictal period, during the first 2-4 hours of the attack. In interictal period, blood was collected at least 24 hours before and after the headache-free period. In the healthy group, blood was collected in the morning after fasting for eight hours.
Quinolinic acid
Time frame: In ictal period, during the first 2-4 hours of the attack. In interictal period, blood was collected at least 24 hours before and after the headache-free period. In the healthy group, blood was collected in the morning after fasting for eight hours.
Serotonin
Time frame: In ictal period, during the first 2-4 hours of the attack. In interictal period, blood was collected at least 24 hours before and after the headache-free period. In the healthy group, blood was collected in the morning after fasting for eight hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 36497053Kortesi T, Spekker E, Vecsei L. Exploring the Tryptophan Metabolic Pathways in Migraine-Related Mechanisms. Cells. 2022 Nov 27;11(23):3795. doi: 10.3390/cells11233795.
- Background: PubMed 27000870Curto M, Lionetto L, Negro A, Capi M, Perugino F, Fazio F, Giamberardino MA, Simmaco M, Nicoletti F, Martelletti P. Altered serum levels of kynurenine metabolites in patients affected by cluster headache. J Headache Pain. 2015;17(1):27. doi: 10.1186/s10194-016-0620-2. Epub 2016 Mar 22.
- Derived from this study: PubMed 38177986Liu J, Xi K, Zhang L, Han M, Wang Q, Liu X. Tryptophan metabolites and gut microbiota play an important role in pediatric migraine diagnosis. J Headache Pain. 2024 Jan 5;25(1):2. doi: 10.1186/s10194-023-01708-9.
- Exploring the Tryptophan Metabolic Pathways in Migraine-Related MechanismsLink provided by the sponsor.
- Altered serum levels of kynurenine metabolites in patients affected by cluster headache.Link provided by the sponsor.
- 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.
Xinjie Liu study director
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine in Children, run by Qilu Hospital of Shandong University at 1 site in China.
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 6 inclusion and 6 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 1 Aug 2023. 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 China. 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. 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 Junhui Liu (15064039296, 15064039296@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tryptophan (time frame: In ictal period, during the first 2-4 hours of the attack. In interictal period, blood was collected at least 24 hours before and after the headache-free period. In the healthy group, blood was collected in the morning after fasting for eight hours.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05969990, which also lists 3 linked publications.
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 1 Aug 2023.