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Intestinal flora transplantation in the treatment of insomnia

Intestinal flora transplantation in the treatment of insomnia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083086
Enrollment
Unknown
Registered
2024-04-15
Start date
2023-09-10
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

Insomnia diseases

Interventions

Sponsors

Wuxi Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (A) Healthy adults aged =18 years; In the past 3 months, the sleep onset time was > 30 minutes, the total sleep time was < 6 hours, the sleep maintenance disorder, the number of awakenings throughout the night was =2, the early awakening, the decreased sleep quality, and daytime dysfunction. The diagnostic criteria of insomnia were: (a) significant dissatisfaction with the quality or quantity of sleep, accompanied by at least one of the following symptoms: difficulty falling asleep, difficulty maintaining sleep, characterized by frequent awakenings or difficulty falling asleep after awakenings, and unable to fall asleep again after waking up early; (b) sleep disturbances (or related daytime fatigue) that cause significant distress or impairment in social, occupational, educational, academic, behavioral, or other important social functioning; (c) dyssomnia occurred more than 3 times per week; (d) sleep difficulty =3 months; (e) sleep difficulties despite adequate sleep opportunities; (B) Voluntarily participated in the study; (C) Being conscious; (D) Able to communicate in language normally.

Exclusion criteria

Exclusion criteria: (A) Suffering from severe cardiovascular and cerebrovascular diseases, respiratory system diseases, immune system diseases, and severe liver and kidney damage; (B) Suffering from severe mental illness, such as depression, generalized anxiety disorder, etc.; (C) Patients with intestinal infection or other infectious diseases; (D) Patients with allergic reactions to gut microbiota transplantation; (E) Patients with intestinal tumors or other intestinal diseases; (F) Patients who fail to provide complete medical history or examination data; (G) For various reasons, the study could not be carried out. (H) Those with fever, pregnancy, lactation, severe systemic infection, etc.; (I) Use of antibiotics in the past 2 weeks; (J) Use of probiotics or immunomodulators in the past month.

Design outcomes

Primary

MeasureTime frame
Sleep assessment scales;Sex hormone;Hepatic and renal function;Immunologic function;Lymphocyte subpopulation;Amplification quantitative culture;Mass spectrum identification;16S rRNA Sequence;Metagenome;

Secondary

MeasureTime frame
Blood fat;Glycated hemoglobin;Infectious disease indicators;

Countries

China

Contacts

Public ContactFeng Ninghan

Wuxi Second People's Hospital

fnh888@njmu.edu.cn+86 138 1395 2696

Outcome results

None listed

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