NCT06361368

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

April 7, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 11, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

May 13, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

April 7, 2024

Last Update Submit

May 9, 2024

Conditions

Insomnia

Keywords

PS150ProbioticsCircadian RhythmPolysomnography

Outcome Measures

Primary Outcomes (1)

  • Polysomnography (PSG)

    According to the polysomnography, we can analysis participants' brain waves (alpha,beta,theta,delta), sleep stages, and autonomic nervous system functioning to evaluate their objective sleep quality.

    Baseline, day30

Secondary Outcomes (19)

  • Pittsburgh Sleep Quality Index (PSQI)

    Baseline, day 30

  • Insomnia Severity Index (ISI)

    Baseline, day 30

  • Beck Depression Inventory-Second Edition (BDI-II)

    Baseline, day 30

  • Beck Anxiety Inventory (BAI)

    Baseline, day 30

  • VAS-Sleep

    Baseline, day 30

  • +14 more secondary outcomes

Study Arms (2)

PS150

EXPERIMENTAL

Each PS150 (Limosilactobacillus fermentum) capsule contained 5 × 10\^9 colony forming units (CFU) , 1 capsule daily use.

Dietary Supplement: PS150

Placebo

PLACEBO COMPARATOR

The placebo capsule contains microcrystalline cellulose, 1 capsule daily use.

Dietary Supplement: Placebo

Interventions

PS150DIETARY_SUPPLEMENT

Participants took one capsule with PS150 after dinner for 30 days.

Also known as: Limosilactobacillus fermentum
PS150
PlaceboDIETARY_SUPPLEMENT

Participants took one capsule with placebo after dinner for 30 days.

Placebo

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Brain Science National Yang Ming Chiao Tung University

Taipei, 112304, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Cheryl C Yang, doctor

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

    STUDY CHAIR

Central Study Contacts

Yu En Kuo, Master

CONTACT

+886 975231262iankuo1106@gmail.com

Cheryl C Yang, doctor

CONTACT

cchyang@gmail.com

Study Design

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

Study Record Dates

First Submitted

April 7, 2024

First Posted

April 11, 2024

Study Start

April 11, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

May 13, 2024

Record last verified: 2024-03

Locations

TW(1)