NCT05969990

Brief 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. 1.to determine the differences in tryptophan metabolites between children with migraine and healthy children;
  2. 2.to explore the correlation between tryptophan metabolites and migraine attacks
  3. 3.to assess the potential mechanisms of the role of tryptophan metabolites in childhood migraine.
  4. 4.participant recruitment: a certain number of pediatric migraine patients and healthy children were recruited as controls.
  5. 5.data collection: clinical information, medical history, and blood samples were collected from participants.
  6. 6.Tryptophan metabolite analysis: using appropriate experimental techniques, ELISA
  7. 7.comparison of differences in tryptophan metabolites between migraine and control groups, using t-test or Wilcoxon rank sum test.
  8. 8.To assess the value of tryptophan metabolites in the diagnosis of migraine, ROC curve analysis was used to calculate the sensitivity, specificity, and AUC.
  9. 9.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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 1, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

May 15, 2023

Last Update Submit

July 23, 2023

Conditions

Migraine in Children

Keywords

Migraine in Children, tryptophan metabolites

Outcome Measures

Primary Outcomes (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (2)

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

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

Other: tryptophan metabolites in plasma

Interventions

tryptophan metabolites in plasmaOTHER

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

case groupcontrol group

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

100 children with migraine and 100 healthy children

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Junhui Liu

Jinan, 250012, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 36497053BACKGROUND

  • 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.

    PMID: 27000870BACKGROUND

  • Liu 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.

    PMID: 38177986DERIVED

Related Links

Study Officials

  • Xinjie Liu

    Qilu Hospital of Shandong University

    STUDY DIRECTOR

Central Study Contacts

Junhui Liu

CONTACT

1506403929615064039296@163.com

Xinjie Liu

CONTACT

18560086300liuxinjie-ert@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2023

First Posted

August 1, 2023

Study Start

January 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)