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Analysis of Oral Microbiome Characteristics in Adults with Epilepsy and Co-occurring Depression Based on 16S rRNA Sequencing

Analysis of Oral Microbiome Characteristics in Adults with Epilepsy and Co-occurring Depression Based on 16S rRNA Sequencing

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121375
Enrollment
Unknown
Registered
2026-03-30
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Epilepsy with comorbid depression

Interventions

Epilepsy with Comorbid Depression Group:None
Epilepsy Only Group:None
Depression Only Group:None
Healthy Control Group:None

Sponsors

The 940th Hospital of the Joint Logistics Support Force of the People's Liberation Army of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. All study participants must meet the following common inclusion criteria: (1) Age 18–65 years; (2) Confirmed by a dentist in the Department of Oral Medicine at this hospital’s Health Examination Center, through a systematic examination including visual inspection, probing, percussion, and palpation, to be free of oral diseases such as active periodontitis, dental caries, oral ulcers, oral leukoplakia, or abnormal masses; (3) No use of antibiotics, probiotics, or prebiotics within 3 months prior to enrollment; (4) No history of severe malnutrition, active infections, drug abuse, or alcohol abuse; No systemic diseases such as cardiac, hepatic, or renal insufficiency, hypertension, or diabetes; (5) Alert and oriented, with good comprehension and communication skills, and able to cooperate in completing the study procedures; (6) All study participants voluntarily enrolled in this study and signed a written informed consent form. 2. Concurrently, eligible subjects meeting the study inclusion criteria were enrolled at the medical examination center. All subjects completed the Patient Health Questionnaire-9 (PHQ-9) depression scale assessment and were grouped based on their PHQ-9 scores: (1) Those with a PHQ-9 score > 4 were included in the major depressive disorder group, (2) Those with a PHQ-9 score 12 were included in the epilepsy with depression group, 2) Those with an NDDI-E score <= 12 were included in the epilepsy-only group. All study participants signed informed consent forms.

Exclusion criteria

Exclusion criteria: 1. Severe malnutrition, infection, drug abuse or alcoholism; 2. There has been a history of oral diseases in the past three months; 3. Those who have used antibiotics, probiotics or prebiotics within the past three months; 4. In addition to epilepsy, there are other systemic diseases (such as heart, liver and kidney insufficiency, hypertension, diabetes, etc.); 5. Patients lacking in understanding and communication skills; 6. Consciousness disorder or status epilepticus.

Design outcomes

Primary

MeasureTime frame
Oral microbiota characteristics and structural differences (alpha diversity: Chao1 index, Shannon index; beta diversity: unweighted Unifrac distance);

Secondary

MeasureTime frame
Key differentially abundant microbial taxa (species abundance profile);Correlation between oral microbiota and comorbid depression in epilepsy;Neurological Deficit Depression Inventory - Epilepsy version (NDDI-E) score;Patient Health Questionnaire-9 (PHQ-9) score;Oral hygiene status (tooth brushing frequency, smoking history, alcohol consumption, dental caries status);Epilepsy-related clinical characteristics (epilepsy type, seizure frequency, family history of genetic disorders);

Countries

China

Contacts

Public ContactLiu Zhao, Zhang Xinyi

The 940th Hospital of the Joint Logistics Support Force of the People's Liberation Army of China

mingkongmimi@163.com+86 138 9320 6770

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026