Efficacy of Lactiplantibacillus plantarum BGI-N6 on relieving insomnia symptoms in patients newly diagnosed with sleep disorder: a randomized, double-blind, placebo-controlled study

INTERVENTION: Experimental group:Probiotic administration;Placebo group:Placebo administration; CONDITION: Sleep disorder (insomnia symptoms) PRIMARY OUTCOME: Pittsburgh Sleep Quality Index (PSQI) score after 4 weeks of intervention; SECONDARY OUTCOME: Changes in gut microbiota;Adverse event;Post‐intervention objective sleep quality index;Changes in serum biomarkers;Response rate of intervention efficacy;Insomnia Severity Inde X(ISI) score;Vital signs;Incidence of psychiatric comorbidities;Pittsburgh Sleep Quality Inde X(PSQI) score after 2 weeks of intervention;Laboratory examinations;Incidence of somatic symptoms associated with sleep disorder (insomnia);Changes in gut microbiota‐derived metabolites;Self‐Rating Anxiety Scale (SAS) score;Self‐Rating Depression Scale (SDS) score; INCLUSION CRITERIA: 1. Age: 18 ‐ 65 years old, gender not restricted; 2. The initial diagnosis meets the diagnostic criteria for chronic insomnia as defined in the International Classification of Sleep Disorders (Third Edition) (ICSD‐3), and simultaneously presents the symptoms listed in (1) ‐ (5): (1) Difficulty falling asleep, difficulty maintaining sleep, early awakening; (2) At least one symptom related to nighttime sleep difficulties: daytime fatigue or sleepiness, impaired attention or memory, emotional instability or irritability, lack of energy, dissatisfaction with sleep; (3) Difficulty falling asleep cannot be simply explained by insufficient sleep opportunities (such as adequate sleep time) or poor sleep environment (such as a dark, safe and quiet comfortable environment); (4) The sleep disorders and related daytime symptoms occur at least 3 times per week and persist for at least 1 month; (5) Sleep difficulties cannot be better explained by another sleep disorder; 3.