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A randomized controlled clinical trial to evaluate the efficacy and safety of PS128 psychotropic probiotics in children with migraine

A randomized controlled clinical trial to evaluate the efficacy and safety of PS128 psychotropic probiotics in children with migraine

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079032
Enrollment
Unknown
Registered
2023-12-24
Start date
2022-12-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pediatric migraine

Interventions

test group:Lactobacillus plantarum strain PS128+cyproheptadine
control group:Cyproheptadine

Sponsors

Qilu Hospital of Shandong university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria. (1) Age 6-18 years, both sexes. (2) Meet ICHD-3 diagnostic criteria for migraine with aura, without aura, and chronic migraine. (3) Migraine diagnosed by two or more specialist neurologists. (4) PedMIDAS score = 11 (5) Migraine has never been treated. (6) Migraine attack characteristics are met: duration of illness >6 months; frequency of attacks >15 times/month; duration of each headache >4h; headache of moderate to severe severity. (7) Patients and family members have given informed consent to the study's purpose, significance, risks, benefits, and informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria. (1) presence of drug overdose (2) autoimmune diseases (3) neurological disorders other than migraine, intracranial masses (4) congenital or genetic disorders (5) diabetes, bronchial asthma, cardiovascular disease, pulmonary disease (6) other types of primary and secondary headache.

Design outcomes

Primary

MeasureTime frame
Relief rates of pediatric migraine;

Secondary

MeasureTime frame
duration of migraine;VAS score of migraine;PACAP-38;CGRP;concomitant symptoms;aura symptoms;

Countries

China

Contacts

Public ContactXinjie Liu

Qilu Hospital of Shandong University

15064039296@163.com+86 185 6008 6300

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026