The Effects of Lactobacillus Plantarum PS128 in Self-Reported Insomniacs

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592276
• Other study ID #: YM107081E
• Status: Completed
• Phase: N/A
• Start date: October 11, 2018
• Est. completion date: December 27, 2019

Study information

• Verified date: August 2018
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 27, 2019
• Est. primary completion date: December 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Dietary Supplement:
• PS128
Participants took two capsules with PS128 after dinner for 30 days.
• placebo
Participants took two capsules without PS128 after dinner for 30 days.

Locations

Country	Name	City	State
Taiwan	Institute of Brain Science National Yang Ming University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Yang Ming University	Bened Biomedical Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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