The Effects of Lactobacillus Plantarum PS128 in Self-Reported Insomniacs

Study Overview
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Brief Summary
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To determine whether PS128 (1) reduces the severity of anxiety and depressive symptoms, (2) adjusts autonomic nervous system functioning, and (3) improves sleep quality.

Detailed Description
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Forty participants with self-reported insomnia between 20 and 40 years old were randomly assigned to two groups, the PS128 and a placebo group, under the double-blind trial. Participants took two capsules with or without PS128 after dinner for 30 days. Study measures included subjective depressive symptoms, anxiety and sleep questionnaires, and miniature polysomnography (miniature-PSG) recordings at baseline and on the 15th and 30th days after taking capsules.

Official Title
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The Effects of Lactobacillus Plantarum PS128 on Depression, Anxiety, Cerebral Rhythms, Autonomic Nervous System Function and Sleep Patterns in Self-Reported Insomniacs

Conditions
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Insomnia

Intervention / Treatment
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* Dietary Supplement: PS128
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) aged 20-40 years old, (2) 18.5 < BMI < 25, (3) BP < 140 mmHg/90 mmHg, (4) PSQI >5, ISI>13, (5) meet the DSM-5 criteria for chronic primary insomnia. Exclusion Criteria: (1) used other probiotic products within the last two weeks, (2) antibiotic treatment within the last month, (3) taken sleep medication within the last two months or were on long-term use, (4) reported tobacco, alcohol, caffeine or drug addiction, (5) lactic acid bacteria allergy, (6) cancer, cardiovascular disease, psychiatric illness, kidney disease, diabetes mellitus or other sleep disorders, (7) inflammatory bowel disease, (8) hepatobiliary gastrointestinal tract surgery (9) worked the night shift.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PS128<br>Each PS128 capsule contained 3 × 10^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg . | Dietary Supplement: PS128<br>* Participants took two capsules with PS128 after dinner for 30 days.<br>* Other names: Lactobacillus plantarum;|
| Placebo Comparator: placebo<br>The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose. | Dietary Supplement: placebo<br>* Participants took two capsules without PS128 after dinner for 30 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in sleep EEG before and after the consumption of probiotics compared to the placebo group. | According to sleep EEG,we can analysis participants' brain waves (alpha,beta,theta,delta) and sleep stages,etc. to evaluate their objective sleep quality. | Baseline, day15 and day30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in The Beck Depression Inventory II (BDI-II) before and after the consumption of probiotics compared to the placebo group. | The Beck Depression Inventory II (BDI-II) is a 21-item, self-rated scale that evaluates key symptoms of depression. It rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. A higher score reflects greater symptoms of depression. | Baseline, day15 and day30 | 
| Differences in the Beck Anxiety Inventory (BAI) before and after the consumption of probiotics compared to the placebo group. | the Beck Anxiety Inventory (BAI) is a 21-item, self-rated scale that evaluates anxiety levels , rated on a scale from 0 to 3. Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety.The maximum total score is 63.A higher score reflects greater anxiety. | Baseline, day15 and day30 | 
| Differences in The Pittsburgh Sleep Quality Index (PSQI) before and after the consumption of probiotics compared to the placebo group. | The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.The maximum total score is 21. A higher score reflects more poor sleep quality. | baseline and day30 | 
| Differences in the Insomnia Severity Index (ISI) before and after the consumption of probiotics compared to the placebo group. | Designed as a brief screening tool for insomnia, the seven-item questionnaire asks respondents to rate the nature and symptoms of their sleep problems using a Likert-type scale. Responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia.The maximum total score is 28. | Baseline, day15 and day30 | 
| Differences in the Epworth Sleepiness Scale (ESS) before and after the consumption of probiotics compared to the placebo group. | The Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of sleepiness. The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. | Baseline, day15 and day30 | 
| Differences in heart rate variability (HRV) before and after the consumption of probiotics compared to the placebo group. | HRV is measured by the variatrasions in the R-R interval between the successive peaks of the QRS complex in the ECG wave. Based on fast Fourier transform, time-domain (R-R interval) transfer to frequency domain resulting total power (TP, 0.0-0.4), low frequency (LF, 0.04-0.15Hz), high frequency (HF, 0.15-0.4Hz), normalized LF (LF%) and LF/HF ratio are obtained. LF% and HF represent an index of sympathetic activity and parasympathetic activity respectively. LF/HF is indicative of the sympathetic to paympathetic autonomic balance. | Baseline, day15 and day30 | 
| Differences in Visual Analogue Scale (VAS) before and after the consumption of probiotics compared to the placebo group. | Visual Analogue Scale (VAS) consists of a line, 10 cm in length. Individuals point to or mark a spot on the line where they feel indicates their current their emotion, fatigue level and sleep quality. The score of emotion level is from 0cm (very nervous) to 10 cm (very relaxing). The score of fatigue level is from 0 cm (very energetic) to 10 cm (very sleepy). The score of sleep quality is from 0 cm (poor) to 10 cm (sleep well). The maximum total score is 100% (equal 10cm). | Baseline, day15 and day30 | 
| Differences in the State and Trait Anxiety Index (STAI) before and after the consumption of probiotics compared to the placebo group. | The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. The score of state anxiety is from 0 to 80.The score of trait anxiety is from 0 to 80. Higher values represent a worse outcome. | Baseline, day15 and day30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PS128, Anxiety, Depression, Electroencephalography