NCT04592276

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Last Updated

July 21, 2022

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

October 12, 2020

Last Update Submit

July 18, 2022

Conditions

Insomnia

Keywords

PS128AnxietyDepressionElectroencephalography

Outcome Measures

Primary Outcomes (1)

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

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

    Baseline, day15 and day30

Secondary Outcomes (8)

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

    Baseline, day15 and day30

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

    Baseline, day15 and day30

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

    baseline and day30

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

    Baseline, day15 and day30

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

    Baseline, day15 and day30

  • +3 more secondary outcomes

Study Arms (2)

PS128

EXPERIMENTAL

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

Dietary Supplement: PS128

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

PS128DIETARY_SUPPLEMENT

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

Also known as: Lactobacillus plantarum
PS128
placeboDIETARY_SUPPLEMENT

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

placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Brain Science National Yang Ming University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Cheryl C Yang, doctor

    Institute of Brain Science ,National Yang-Ming University, Taipei City, Taiwan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2020

First Posted

October 19, 2020

Study Start

October 11, 2018

Primary Completion

December 27, 2019

Study Completion

December 27, 2019

Last Updated

July 21, 2022

Record last verified: 2018-08

Locations

TW(1)