The Effects of Lactobacillus Plantarum PS128 in Self-Reported Insomniacs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-11

Study Completion Date

2019-12-27

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.

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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.

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PS128

Each PS128 capsule contained 3 × 10\^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg .

Group Type EXPERIMENTAL

PS128

Intervention Type DIETARY_SUPPLEMENT

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

placebo

The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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PS128

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

Intervention Type DIETARY_SUPPLEMENT

placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Lactobacillus plantarum

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No