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Probiotics can improve insomnia and anxiety of college students by regulating intestinal flora and its metabolites

Probiotics can improve insomnia and anxiety of college students by regulating intestinal flora and its metabolites

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083149
Enrollment
Unknown
Registered
2024-04-16
Start date
2023-11-20
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Insomnia and anxiety

Interventions

Healthy control group:none
placebo group:Use of placebo preparations that are identical to probiotic preparations except for the probiotic ingredients
probiotic group:Use of probiotic-containing preparations

Sponsors

Nanchang Reproductive Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: Healthy control group: 1 gender is not limited, age = 18 years old , = 30 years old 2 Hamilton Anxiety Scale (score 6) 4 the clinical manifestations of depressed state of mind, and accompanied by at least four of the following: ? often inexplicable nervousness, anxiety; ? like to complain, easy to get agitated, some small things and lose their temper, nagging; ? poor concentration, memory loss, a sense of fatigue, energy; ? accompanied by a series of somatic symptoms, such as sleep disorders, early awakening, insomnia, dreaming, and sleep, poor appetite, weight loss tendency; ?, a series of symptoms, such as sleep disorders, early awakening, insomnia, dreams and sleep, poor appetite, weight loss tendency; ?, a series of symptoms, such as sleep disorders, early awakening, insomnia, dreams and sleep Weight loss tendency, etc.; ? always have a sad expression, unwilling to talk to others; ? less activity, slow reaction; ? have a sense of guilt, self-blame, low self-evaluation. 5 Have not taken probiotics or other medications for one month 6 Signed informed consent

Exclusion criteria

Exclusion criteria: 1: Smoking, alcohol abuse; 2: Received medications such as antidiarrheal, bulking agents, probiotics, antispasmodics, and antibiotics within 30 days prior to enrollment; 3: Severe cardiac, pulmonary, renal, and hepatic dysfunction as well as metabolic diseases, received radiotherapy, chemotherapy, etc..

Design outcomes

Primary

MeasureTime frame
Hamilton Anxiety Inventory;Assens Insomnia Scale;High-throughput sequencing; Untargeted metabolomics; Human Salivary Cortisol (SC) ELISA;

Countries

China

Contacts

Public ContactTingtao Chen ; Weijun Chen

Nanchang University/ Nanchang Reproductive Hospital

chentingtao1984@163.com+86 139 7919 6862

Outcome results

None listed

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