Clinical trial NCT04592276: The Effects of Lactobacillus Plantarum PS128 in Self-Reported Insomniacs
Official title: The Effects of Lactobacillus Plantarum PS128 on Depression, Anxiety, Cerebral Rhythms, Autonomic Nervous System Function and Sleep Patterns in Self-Reported Insomniacs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: PS128
Anxiety
Depression
Electroencephalography
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: Bened Biomedical Co., Ltd.
First posted: 2020-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Differences in sleep EEG before and after the consumption of probiotics compared to the placebo group.
timeFrame: Baseline, day15 and day30
Secondary outcomes:
measure: Differences in The Beck Depression Inventory II (BDI-II) before and after the consumption of probiotics compared to the placebo group.
timeFrame: Baseline, day15 and day30
measure: Differences in the Beck Anxiety Inventory (BAI) before and after the consumption of probiotics compared to the placebo group.
timeFrame: Baseline, day15 and day30
measure: Differences in The Pittsburgh Sleep Quality Index (PSQI) before and after the consumption of probiotics compared to the placebo group.
timeFrame: baseline and day30
measure: Differences in the Insomnia Severity Index (ISI) before and after the consumption of probiotics compared to the placebo group.
timeFrame: Baseline, day15 and day30
measure: Differences in the Epworth Sleepiness Scale (ESS) before and after the consumption of probiotics compared to the placebo group.
timeFrame: Baseline, day15 and day30
measure: Differences in heart rate variability (HRV) before and after the consumption of probiotics compared to the placebo group.
timeFrame: Baseline, day15 and day30
measure: Differences in Visual Analogue Scale (VAS) before and after the consumption of probiotics compared to the placebo group.
timeFrame: Baseline, day15 and day30
measure: Differences in the State and Trait Anxiety Index (STAI) before and after the consumption of probiotics compared to the placebo group.
timeFrame: Baseline, day15 and day30
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Institute of Brain Science National Yang Ming University
Study officials:
affiliation: Institute of Brain Science ,National Yang-Ming University, Taipei City, Taiwan
name: Cheryl C Yang, doctor
role: STUDY_CHAIR
References: