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Clinical study of ''Microflora intervention therapy'' for sleep disorders combined with metabolic syndrome

Clinical study of ''Microflora intervention therapy'' for sleep disorders combined with metabolic syndrome

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069452
Enrollment
Unknown
Registered
2023-03-16
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

insomnia disorder

Interventions

experimental group:Probiotic intervention for 4 weeks, 6g/ day
control group:Placebo was given for 4 weeks at 6g/ day

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The inclusion criteria for ID subjects :A. Meet the diagnostic criteria for ID in the American Diagnostic and Statistical Manual of Mental Disorders (5th Edition) and the Chinese Criteria for Classification and Diagnosis of Mental Disorders (3rd Edition); B. In line with the scale and objective criteria for PSG diagnosis ID, the scale score required PSQI27 points; C. Age 18-60

Exclusion criteria

Exclusion criteria: Exclusion criteria :A. Insomnia caused by sleep disorders, such as obstructive sleep apnea syndrome, sleep periodic limb movement, etc.; B. severe suicidal ideation, severe mental disorder; C. Has or currently has a history of tobacco, alcohol and drug abuse; E. pregnancy; F. Taking antibiotics for more than 3 days within 1 month; G History of mental and neurological diseases, history of head trauma; H. Hereditary diseases in the family; I History of major physical illness.

Design outcomes

Primary

MeasureTime frame
Head MRI;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index;Insomnia severity index scale,ISI;Hamilton Depression Scale, HAMD;Beck Depression Inventory,BDI;20-item Toronto Alexithymia Scale,TAS-20;15-item Emotional Contagion Scale,EC;Positive Affect and Negative Affect Scale,PANAS;Portable polysomnography;glucocorticoid;

Countries

China

Contacts

Public ContactYongli Li

Henan Provincial People's Hospital

shyliyongli@126.com+86 136 3381 2936

Outcome results

None listed

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