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Completed

NCT Number: NCT04592276

The Effects of Lactobacillus Plantarum PS128 in Self-Reported Insomniacs

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

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Brain Science National Yang Ming University

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PS128

Dietary Supplement

Participants took two capsules with PS128 after dinner for 30 days.

Other names: Lactobacillus plantarum

Placebo

Dietary Supplement

Participants took two capsules without PS128 after dinner for 30 days.

Primary outcomes

  1. Differences in sleep EEG before and after the consumption of probiotics compared to the placebo group.

    Time frame: Baseline, day15 and day30

    According to sleep EEG,we can analysis participants' brain waves (alpha,beta,theta,delta) and sleep stages,etc. to evaluate their objective sleep quality.

Secondary outcomes

  1. Differences in The Beck Depression Inventory II (BDI-II) before and after the consumption of probiotics compared to the placebo group.

    Time frame: Baseline, day15 and day30

    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.

  2. Differences in the Beck Anxiety Inventory (BAI) before and after the consumption of probiotics compared to the placebo group.

    Time frame: Baseline, day15 and day30

    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.

  3. Differences in The Pittsburgh Sleep Quality Index (PSQI) before and after the consumption of probiotics compared to the placebo group.

    Time frame: baseline and day30

    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.

  4. Differences in the Insomnia Severity Index (ISI) before and after the consumption of probiotics compared to the placebo group.

    Time frame: Baseline, day15 and day30

    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.

  5. Differences in the Epworth Sleepiness Scale (ESS) before and after the consumption of probiotics compared to the placebo group.

    Time frame: Baseline, day15 and day30

    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.

  6. Differences in heart rate variability (HRV) before and after the consumption of probiotics compared to the placebo group.

    Time frame: Baseline, day15 and day30

    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.

  7. Differences in Visual Analogue Scale (VAS) before and after the consumption of probiotics compared to the placebo group.

    Time frame: Baseline, day15 and day30

    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).

  8. Differences in the State and Trait Anxiety Index (STAI) before and after the consumption of probiotics compared to the placebo group.

    Time frame: Baseline, day15 and day30

    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.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Collaborators

  • Bened Biomedical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2020
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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