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Recruiting NCT06361368

Efficacy Assessment of Probiotics in Improving Sleep Indices

Trial Parameters

Condition Insomnia
Sponsor National Yang Ming Chiao Tung University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 140
Sex ALL
Min Age 20 Years
Max Age 60 Years
Start Date 2024-04-11
Completion 2026-03
Interventions
PS150Placebo

Brief Summary

To determine whether PS150 (1) reduces insomnia symptoms, (2) improves sleep quality, (3) adjusts autonomic nervous system functioning, (4) reduces the severity of anxiety and depressive symptoms, and (5) adjusts microbiome and endocrine functions.

Eligibility Criteria

Inclusion Criteria: 1. aged 20-60 years old, 2. self-reported Insomnia (PSQI ≥ 7 \& 22 \> ISI ≥ 12), 3. 17.5 \< BMI \< 35 kg/m\^2, and 4. regular sleep cycle. Exclusion Criteria: 1. used antibiotic, sleep aids, tranquilizers, or antipsychotic treatment within the last month, 2. used other probiotic products within the last month, 3. taking medications known to commonly induce sleep disorders (such as corticosteroids, antihistamines, and stimulants, etc.) or currently undergoing hormone therapy, including contraceptive pills, 4. have undergone hepatobiliary gastrointestinal tract surgery 5. lactic acid bacteria allergy, 6. with cancer, cardiovascular disease, psychiatric illness, or kidney disease, 7. with uncontrolled diabetes mellitus or hypertension, 8. with sleep disorders other than insomnia, 9. allergic to lactobacillus, 10. reported tobacco, alcohol, caffeine or drug addiction, 11. traveled to different time zone in long-distance trip within the last month, 12. participated in ot

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