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InsomniaNCT06361368

Efficacy Assessment of Probiotics in Improving Sleep Indices

A study testing PS150 in people with Insomnia, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Insomnia
What is being tested?
PS150
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
1 siteTaiwan
Study dates
15 Feb 2024to 29 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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,
Show all 13Show fewer
  • 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 locations and contacts

1 site in 1 country.

Taiwan1 site
  • Institute of Brain Science National Yang Ming Chiao Tung University

    Taipei, 112304

Other trials in Taiwan

About this study

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.

Read the detailed 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.

Conditions
Insomnia
Being tested
PS150, Placebo
Keywords
PS150, Probiotics, Circadian Rhythm, Polysomnography
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PS150Dietary supplement

    Also called Limosilactobacillus fermentum

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

  • PlaceboDietary supplement

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

Study groups in NCT06361368
Study groupRoleWhat they receive
PS150ExperimentalEach PS150 (Limosilactobacillus fermentum) capsule contained 5 × 10^9 colony forming units (CFU) , 1 capsule daily use.
Receives: Dietary Supplement: PS150
PlaceboPlacebo comparatorThe placebo capsule contains microcrystalline cellulose, 1 capsule daily use.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, day30

Secondary outcomes (19)
  1. Pittsburgh Sleep Quality Index (PSQI)

    The Pittsburgh Sleep Quality Index (PSQI) is a self-rated inventory that assesses sleep quality over the past 1-month. The measure consists of 19 individual items, creating 7 components that produce one global score. It takes 5-10 minutes to complete.The maximum global score is 21. A higher score reflects more poor sleep quality.

    Measured: Baseline, day 30

  2. Insomnia Severity Index (ISI)

    The Insomnia Severity Index (ISI) is designed as a brief screening tool for insomnia. The seven-item questionnaire asks respondents to rate the nature and symptoms of their sleep problems using a 5-Likert scale. Responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia.The maximum total score is 28.

    Measured: Baseline, day 30

  3. Beck Depression Inventory-Second Edition (BDI-II)

    The Beck Depression Inventory-Second Edition (BDI-II) is a 21-item, self-rated inventory that evaluates key symptoms of depression. It rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. A higher score reflects greater symptoms of depression.

    Measured: Baseline, day 30

  4. Beck Anxiety Inventory (BAI)

    The Beck Anxiety Inventory (BAI) is a 21-item, self-rated inventory that evaluates anxiety levels. It rated on a scale from 0 to 3. Each item is descriptive of subjective, somatic, or panic-related anxious symptoms.The maximum total score is 63. A higher score reflects greater symptoms of anxiety.

    Measured: Baseline, day 30

  5. VAS-Sleep

    Visual Analogue Scale (VAS) consists of a line, 10 cm in length. Individuals point to or mark a spot on the line where they feel indicates their current their emotion, fatigue level and sleep quality. The score of emotion level is from 0cm (very nervous) to 10 cm (very relaxing). The score of fatigue level is from 0 cm (very energetic) to 10 cm (very sleepy). The score of sleep quality is from 0 cm (poor) to 10 cm (sleep well). The maximum total score is 100% (equal 10cm).

    Measured: Baseline, day 30

  6. Epworth Sleepiness Scale (ESS)

    The Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of sleepiness. It is a list of eight situations in which you rate your tendency to become sleepy. Each item is rated on the scale from 0, no chance of dozing, to 3, high chance of dozing.

    Measured: Baseline, day 30

  7. Stanford Sleepiness Scale (SSS)

    The Stanford Sleepiness Scale (SSS) is a 7-point Likert inventory to evaluate a respondent's sleepiness at the time when it is completed.

    Measured: Baseline, day 30

  8. Visual Analogue Scale for gastrointestinal symptoms (VAS-GI)

    Visual Analogue Scale for GI symptoms, VAS-GI (visual analogue scale, VAS 0-10) was designed to measure the response of symptoms and well-being in respondents before and after taking PS150 or Placebo.

    Measured: Baseline, day 30

  9. Saliva Melatonin

    pg/ml of melatonin in saliva measured by enzyme-linked immunosorbent assay.

    Measured: Baseline, day 30

  10. Saliva Cortisol

    Cortisol is a steroid hormone that is produced by the adrenal glands which sit on top of each kidney. When released into the bloodstream, cortisol can act on many different parts of the body and can help:

    body respond to stress or danger increase your body's metabolism of glucose control your blood pressure reduce inflammation. Cortisol is also needed for the fight or flight response which is a healthy, natural response to perceived threats. The amount of cortisol produced is highly regulated by your body to ensure the balance is correct.

    Measured: Baseline, day 30

  11. Saliva Interleukin-6 (IL-6)

    Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80°C. Enzyme-linked immunosorbent assays were used to quantify IL-6 amount (ng/mL).

    Measured: Baseline, day 30

  12. Saliva Total Antioxidant Capacity (TAC)

    Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80°C. Enzyme-linked immunosorbent assays were used to quantify TAC amount (nmol/mL).

    Measured: Baseline, day 30

  13. Saliva Serotonin

    Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80°C. Enzyme-linked immunosorbent assays were used to quantify serotonin amount (ng/mL).

    Measured: Baseline, day 30

  14. Saliva gamma-aminobutyric acid (GABA)

    Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80°C. Enzyme-linked immunosorbent assays were used to quantify GABA amount (pg/mL).

    Measured: Baseline, day 30

  15. Saliva Orexin

    Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80°C. Enzyme-linked immunosorbent assays were used to quantify Orexin amount.

    Measured: Baseline, day 30

  16. Urine 6-sulfatoxymelatonin

    In order to determine the levels of 6-sulphatoxymelatonin from patients in the experimental and control groups, urine samples will be taken between between 21:00 to 23:00 at night. A urine sample will be taken into a sample container containing 10-15 ml of 6 M hydrochloric acid (HCl) and stored at -80 degrees for analysis in the biochemistry laboratory.

    Measured: Baseline, day 30

  17. Urine Norepinephrine

    In order to determine the levels of norepinephrine from patients in the experimental and control groups, urine samples will be taken between between 21:00 to 23:00 at night. A urine sample will be taken into a sample container containing 10-15 ml of 6 M hydrochloric acid (HCl) and stored at -80 degrees for analysis in the biochemistry laboratory.

    Measured: Baseline, day 30

  18. Actigraphy

    Actigraph will be placed on the non-dominant wrist and activities will be monitored continuously and recorded at one minute intervals during wakefulness and sleep.

    The times of wakefulness and sleep will be determined individually through a diary kept by the participants, together with the times calculated by the actigraph monitor.

    The participants will keep the device for a period of 7 days before and the last 7-day of training session. The device will be removed only at bath time and replaced to the wrist immediately after.

    Measured: Baseline, day 30

  19. Sleep Diary

    The sleep diary is a daily self-reported 12-item form within 30 minutes after wake up. It assesses respondent's time taken to fall asleep (sleep onset latency), wake after sleep onset, total sleep, total time in bed, and sleep efficiency, etc.

    Measured: Baseline, day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study start15 Feb 2024
  3. Primary completion29 Dec 2025
  4. Study completion29 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06361368
Sponsor's protocol ID
NYCU112174AF
Status last verified
Oct 2026
First submitted
7 Apr 2024
Last updated
30 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing PS150 in people with Insomnia, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Polysomnography (PSG) (time frame: Baseline, day30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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