Clinical trial NCT06361368: Efficacy Assessment of Probiotics in Improving Sleep Indices
Official title: Efficacy Assessment of Probiotics in Improving Sleep Indices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: PS150
Probiotics
Circadian Rhythm
Polysomnography
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: Bened Biomedical Co., Ltd.
First posted: 2024-04-11
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Polysomnography (PSG)
timeFrame: Baseline, day30
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, day 30
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, day 30
measure: Beck Depression Inventory-Second Edition (BDI-II)
timeFrame: Baseline, day 30
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline, day 30
measure: VAS-Sleep
timeFrame: Baseline, day 30
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, day 30
measure: Stanford Sleepiness Scale (SSS)
timeFrame: Baseline, day 30
measure: Visual Analogue Scale for gastrointestinal symptoms (VAS-GI)
timeFrame: Baseline, day 30
measure: Saliva Melatonin
timeFrame: Baseline, day 30
measure: Saliva Cortisol
timeFrame: Baseline, day 30
measure: Saliva Interleukin-6 (IL-6)
timeFrame: Baseline, day 30
measure: Saliva Total Antioxidant Capacity (TAC)
timeFrame: Baseline, day 30
measure: Saliva Serotonin
timeFrame: Baseline, day 30
measure: Saliva gamma-aminobutyric acid (GABA)
timeFrame: Baseline, day 30
measure: Saliva Orexin
timeFrame: Baseline, day 30
measure: Urine 6-sulfatoxymelatonin
timeFrame: Baseline, day 30
measure: Urine Norepinephrine
timeFrame: Baseline, day 30
measure: Actigraphy
timeFrame: Baseline, day 30
measure: Sleep Diary
timeFrame: Baseline, day 30
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Institute of Brain Science National Yang Ming Chiao Tung University
Study officials:
affiliation: Institute of Brain Science ,National Yang Ming Chiao Tung University, Taipei City, Taiwan
name: Cheryl C Yang, doctor
role: STUDY_CHAIR
References: