Migraine in Children Clinical Trial
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. 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: 1. to determine the differences in tryptophan metabolites between children with migraine and healthy children; 2. to explore the correlation between tryptophan metabolites and migraine attacks 3. to assess the potential mechanisms of the role of tryptophan metabolites in childhood migraine. Study methods: 1. participant recruitment: a certain number of pediatric migraine patients and healthy children were recruited as controls. 2. data collection: clinical information, medical history, and blood samples were collected from participants. 3. Tryptophan metabolite analysis: using appropriate experimental techniques, ELISA Statistical analysis: The main analyses included the following: 1. comparison of differences in tryptophan metabolites between migraine and control groups, using t-test or Wilcoxon rank sum test. 2. To assess the value of tryptophan metabolites in the diagnosis of migraine, ROC curve analysis was used to calculate the sensitivity, specificity, and AUC. 3. 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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 18 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | Junhui Liu | Jinan |
Lead Sponsor | Collaborator |
---|---|
Qilu Hospital of Shandong University |
China,
Curto 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tryptophan | 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. | ||
Primary | Kynurenine | 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. | ||
Primary | Kynurenic acid | 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. | ||
Primary | Quinolinic acid | 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. | ||
Primary | Serotonin | 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. |
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