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A comparative study on the diversity and relative abundance of gut microbiota in patients with insomnia

A comparative study on the diversity and relative abundance of gut microbiota in patients with insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200065480
Enrollment
Unknown
Registered
2022-11-06
Start date
2022-11-06
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Insomnia

Interventions

Insomnia:Anti-insomnia drugs

Sponsors

The First Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Insomnia group: 1. All patients meet the diagnostic criteria of ICSD-3 chronic insomnia, and other sleep disorders are excluded by diagnostic interview for sleep patterns and sleep disorders (DISP); 2. According to the mini-international neuropsychiatric interview (M.I.N.I.) Chinese version 5.0.0 structured meeting, major depressive disorder, anxiety disorder and other mental disorders are excluded; 3. The symptoms of insomnia lasted for more than 3 months; 4. Aged 18-60 years; 5. Insomnia severity index (ISI) score >= 14; 6. The body mass index (BMI) 18.5-23.9 kg/m2. Healthy controls: 1. According to DISP, sleep disorders are excluded; 2. According to the M.I.N.I. structured meeting, mental disorders are excluded; 3. Aged 18-60 years; 4. Insomnia severity index (ISI) score < 14; 5. The body mass index (BMI) 18.5-23.9 kg/m2.

Exclusion criteria

Exclusion criteria: 1. Complicated with severe somatic or brain organic diseases; 2. Complicated with other mental disorders, personality disorder or psychoactive substance abuse or dependence; 3. Complicated with other sleep disorders, including excessive daytime drowsiness, sleep-related respiratory diseases, sleep-related motor disorders or sleep circadian rhythm disorders; 4. Regular consumption of probiotic drugs or drinks in the past 1 month; 5. Antibiotics have been used in the past 3 months; 6. Severe diarrhea in the past 3 months (3 or more water samples per day for 3 days or more); 7. Severe constipation in the past 3 months (defecation twice or less per week, with defecation difficulty); 8. History of regular drinking; 9. Menstrual, pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
gut microbiota;oral microbiota;metabonomics;transcriptome;polysomnography;

Secondary

MeasureTime frame
inflammatory factors;clinical neuropsychological scales;

Countries

China

Contacts

Public ContactJiyang Pan

The first affiliated Hospital of Jinan University

pan_ktz@163.com+86 13022095016

Outcome results

None listed

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