Efficacy Assessment of Probiotics in Improving Sleep Indices

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National Yang Ming University

Status

Enrolling

Conditions

Insomnia

Treatments

Dietary Supplement: PS150
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06361368
NYCU112174AF

Details and patient eligibility

About

To determine whether PS150 (1) reduces insomnia symptoms, (2) improves sleep quality, (3) adjusts autonomic nervous system functioning, (4) reduces the severity of anxiety and depressive symptoms, and (5) adjusts microbiome and endocrine functions.

Full description

One-hundred-forty participants with self-reported insomnia (PSQI≥ 7 & 22 > ISI ≥ 12) aged between 20 and 60 years old are estimated to be recruited and randomly assigned to two arms, the PS150 group and the placebo group, under the double-blinded trial. Participants take one capsule of probiotics or placebo after dinner for 30 days. Study measures include polysomnography (PSG), subjective sleep, depressive, and anxiety questionnaires, sleep diary, fecal sampling, saliva testing, and urine testing.

Enrollment

140 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • aged 20-60 years old,
  • self-reported Insomnia (PSQI ≥ 7 & 22 > ISI ≥ 12),
  • 17.5 < BMI < 35 kg/m^2, and
  • regular sleep cycle.

Exclusion criteria

  • used antibiotic, sleep aids, tranquilizers, or antipsychotic treatment within the last month,
  • used other probiotic products within the last month,
  • taking medications known to commonly induce sleep disorders (such as corticosteroids, antihistamines, and stimulants, etc.) or currently undergoing hormone therapy, including contraceptive pills,
  • have undergone hepatobiliary gastrointestinal tract surgery
  • lactic acid bacteria allergy,
  • with cancer, cardiovascular disease, psychiatric illness, or kidney disease,
  • with uncontrolled diabetes mellitus or hypertension,
  • with sleep disorders other than insomnia,
  • allergic to lactobacillus,
  • reported tobacco, alcohol, caffeine or drug addiction,
  • traveled to different time zone in long-distance trip within the last month,
  • participated in other interventional studies within the last three months, and
  • evaluated as unsuitable participant by PI.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

140 participants in 2 patient groups, including a placebo group

PS150
Experimental group
Description:
Each PS150 (Limosilactobacillus fermentum) capsule contained 5 × 10^9 colony forming units (CFU) , 1 capsule daily use.
Treatment:
Dietary Supplement: PS150
Placebo
Placebo Comparator group
Description:
The placebo capsule contains microcrystalline cellulose, 1 capsule daily use.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Central trial contact

Yu En Kuo, Master; Cheryl C Yang, doctor

Data sourced from clinicaltrials.gov

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