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Development of a Novel Non-Invasive Diagnostic Tool for Autoimmune Epilepsy Based on Oral and Gut Microbiome Metagenomic and Metabolomic Data

Development of a Novel Non-Invasive Diagnostic Tool for Autoimmune Epilepsy Based on Oral and Gut Microbiome Metagenomic and Metabolomic Data

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124181
Enrollment
Unknown
Registered
2026-05-08
Start date
2025-11-06
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Autoimmune epilepsy

Interventions

acute symptomatic seizures secondary to autoimmune encephalitis(ASSAE) group:No
autoimmune-associated epilepsy(AAE) group:No

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. ?Meeting the ILAE (2017) diagnostic criteria for epilepsy, with epilepsy being the sole or primary clinical manifestation ? 2. ?Cerebrospinal fluid (CSF) biochemical analysis showing inflammatory changes 3. ?Serum or cerebrospinal fluid (CSF) testing for anti-neuronal autoantibodies.?

Exclusion criteria

Exclusion criteria: 1. ?The epilepsy is clearly caused by etiologies other than immune factors, such as genetic factors, structural abnormalities, metabolic disorders, infections, or tumors 2. ?The presence of other systemic diseases, such as hypertension, endocrine disorders, cardiovascular diseases, hepatic or renal dysfunction, diabetes mellitus, intestinal diseases, or chronic diarrhea and constipation ? 3. ?Use of any antibiotics or probiotic preparations during the follow-up period, or consumption of yogurt as part of the diet? 4. ?Pregnant or lactating women, individuals with a history of psychiatric disorders, or those unable to comply with the study procedures.?

Design outcomes

Primary

MeasureTime frame
NMDAR antibodies;LGI1 protein antibodies;CSF WBC count(×10?/L);MOG antibodies;CSF IgG index;GABA-A/BR antibodies;VEEG;CSF total protein concentration ( mg/dL or g/L)?;GAD65 antibodies;CSF oligoclonal bands;Serum immunoglobulin quantification;

Countries

China

Contacts

Public ContactJiang Yan

The First Affiliated Hospital of Zhengzhou University

15838960048@163.com+86 371 6627 8076

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026