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Discovery of functional strains and biomarker screening for chronic insomnia based on the multi-dimensional microbiome (gut-oral)–gut-brain axis

Discovery of functional strains and biomarker screening for chronic insomnia based on the multi-dimensional microbiome (gut-oral)–gut-brain axis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600130541
Enrollment
Unknown
Registered
2026-08-21
Start date
2026-08-21
Completion date
Unknown
Last updated
2026-08-24

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

Conditions

Chronic Insomnia

Interventions

Insomnia patients:No

Sponsors

Hangzhou Seventh People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18 - 65 years old (inclusive of 18 and 65); 2. The insomnia patient group met the diagnostic criteria for insomnia disorder as per DSM-5; the healthy control group had no complaints of insomnia and their PSQI score was <= 5 points. 3. Not using antibiotics or probiotic preparations for the past 4 weeks; 4. Be able to complete questionnaire and scale assessments; 5. Voluntary signing of the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe physical diseases (such as tumors, immune system disorders, severe gastrointestinal diseases, etc.); 2. Severe mental disorders (such as schizophrenia, bipolar disorder, depression with suicidal risk, mental retardation, dementia, etc.); 3. Other insomnia caused by severe sleep disorders (such as severe sleep apnea, restless legs syndrome, circadian rhythm disorders, etc.); 4. Patients with active oral diseases (such as severe periodontitis, oral mucosal diseases, etc.); 5. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
flora;

Countries

China

Contacts

Public ContactLiu Wenjuan

Hangzhou Seventh People's Hospital

94129378@qq.com+86 571 85126878

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026