Efficacy Assessment of Probiotics in Improving Sleep Indices

Efficacy Assessment of Probiotics in Improving Sleep Indices

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.

One-hundred-forty participants with self-reported insomnia (PSQI≥ 7 & 22 > ISI ≥ 12) aged between 20 and 60 years old are estimated to be recruited and randomly assigned to two arms, the PS150 group and the placebo group, under the double-blinded trial. Participants take one capsule of probiotics or placebo after dinner for 30 days. Study measures include polysomnography (PSG), subjective sleep, depressive, and anxiety questionnaires, sleep diary, fecal sampling, saliva testing, and urine testing.

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 other interventional studies within the last three months, and
13. evaluated as unsuitable participant by PI.