Efficacy Assessment of Probiotics in Improving Sleep Indices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Polysomnography (PSG)
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aged 20-60 years old,
- •self-reported Insomnia (PSQI ≥ 7 & 22 > ISI ≥ 12),
- •17.5 < BMI < 35 kg/m^2, and
- •regular sleep cycle.
Exclusion Criteria
- •used antibiotic, sleep aids, tranquilizers, or antipsychotic treatment within the last month,
- •used other probiotic products within the last month,
- •taking medications known to commonly induce sleep disorders (such as corticosteroids, antihistamines, and stimulants, etc.) or currently undergoing hormone therapy, including contraceptive pills,
- •have undergone hepatobiliary gastrointestinal tract surgery
- •lactic acid bacteria allergy,
- •with cancer, cardiovascular disease, psychiatric illness, or kidney disease,
- •with uncontrolled diabetes mellitus or hypertension,
- •with sleep disorders other than insomnia,
- •allergic to lactobacillus,
- •reported tobacco, alcohol, caffeine or drug addiction,
- •traveled to different time zone in long-distance trip within the last month,
- •participated in other interventional studies within the last three months, and
- •evaluated as unsuitable participant by PI.
Outcomes
Primary Outcomes
Polysomnography (PSG)
Time Frame: Baseline, day30
According to the polysomnography, we can analysis participants' brain waves (alpha,beta,theta,delta), sleep stages, and autonomic nervous system functioning to evaluate their objective sleep quality.
Secondary Outcomes
- Urine 6-sulfatoxymelatonin(Baseline, day 30)
- Actigraphy(Baseline, day 30)
- Visual Analogue Scale for gastrointestinal symptoms (VAS-GI)(Baseline, day 30)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, day 30)
- Saliva Total Antioxidant Capacity (TAC)(Baseline, day 30)
- Beck Depression Inventory-Second Edition (BDI-II)(Baseline, day 30)
- Saliva Melatonin(Baseline, day 30)
- Saliva Cortisol(Baseline, day 30)
- Saliva Serotonin(Baseline, day 30)
- Insomnia Severity Index (ISI)(Baseline, day 30)
- Beck Anxiety Inventory (BAI)(Baseline, day 30)
- VAS-Sleep(Baseline, day 30)
- Epworth Sleepiness Scale (ESS)(Baseline, day 30)
- Stanford Sleepiness Scale (SSS)(Baseline, day 30)
- Saliva gamma-aminobutyric acid (GABA)(Baseline, day 30)
- Saliva Interleukin-6 (IL-6)(Baseline, day 30)
- Saliva Orexin(Baseline, day 30)
- Urine Norepinephrine(Baseline, day 30)
- Sleep Diary(Baseline, day 30)