The Effects of Lactobacillus Plantarum PS128 in Self-Reported Insomniacs

National Yang Ming Chiao Tung University

Status

Completed

Conditions

Insomnia

Treatments

Dietary Supplement: placebo

Dietary Supplement: PS128

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04592276

YM107081E

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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.