Tryptophan Metabolites in Pediatric Migraine

NCT05969990 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-08-01

No results posted yet for this study

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 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.

Conditions

  • Migraine in Children

Interventions

OTHER

tryptophan metabolites in plasma

we will investigate the tryptophan metabolites in plasma of children with migraine

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Xinjie Liu · Qilu Hospital of Shandong University

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05969990 on ClinicalTrials.gov