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.
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
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 group | Role | What they receive |
|---|---|---|
| PS150 | Experimental | Each PS150 (Limosilactobacillus fermentum) capsule contained 5 × 10^9 colony forming units (CFU) , 1 capsule daily use. Receives: Dietary Supplement: PS150 |
| Placebo | Placebo comparator | The 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.
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)
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
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
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
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
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
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
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
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
Saliva Melatonin
pg/ml of melatonin in saliva measured by enzyme-linked immunosorbent assay.
Measured: Baseline, day 30
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
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
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
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
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
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
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
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
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
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.
- First posted11 Apr 2024
- Study start15 Feb 2024
- Primary completion29 Dec 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Cheryl C Yang, doctor, Study chair, Institute of Brain Science ,National Yang Ming Chiao Tung University, Taipei City, Taiwan
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Assessment of Probiotics in Improving Sleep Indices
- ClinicalTrials.gov ID
- NCT06361368
- Acronym / sponsor ID
- NYCU112174AF
- Conditions
- Insomnia
- Keywords
- PS150, Probiotics, Circadian Rhythm, Polysomnography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PS150 | Experimental | Dietary Supplement: PS150Each PS150 (Limosilactobacillus fermentum) capsule contained 5 × 10^9 colony forming units (CFU) , 1 capsule daily use. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo capsule contains microcrystalline cellulose, 1 capsule daily use. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- aged 20-60 years old,
- self-reported Insomnia (PSQI ≥ 7 \& 22 > ISI ≥ 12),
- 17.5 < BMI < 35 kg/m^2, and
- regular sleep cycle.
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PS150Also: Limosilactobacillus fermentumParticipants took one capsule with PS150 after dinner for 30 days. | Dietary supplement | PS150 |
| PlaceboParticipants took one capsule with placebo after dinner for 30 days. | Dietary supplement | Placebo |
Primary outcome
Polysomnography (PSG)
Time frame: Baseline, day30
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.
19 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, day 30
Insomnia Severity Index (ISI)
Time frame: Baseline, day 30
Beck Depression Inventory-Second Edition (BDI-II)
Time frame: Baseline, day 30
Beck Anxiety Inventory (BAI)
Time frame: Baseline, day 30
VAS-Sleep
Time frame: Baseline, day 30
Epworth Sleepiness Scale (ESS)
Time frame: Baseline, day 30
Stanford Sleepiness Scale (SSS)
Time frame: Baseline, day 30
Visual Analogue Scale for gastrointestinal symptoms (VAS-GI)
Time frame: Baseline, day 30
Saliva Melatonin
Time frame: Baseline, day 30
Saliva Cortisol
Time frame: Baseline, day 30
Saliva Interleukin-6 (IL-6)
Time frame: Baseline, day 30
Saliva Total Antioxidant Capacity (TAC)
Time frame: Baseline, day 30
Saliva Serotonin
Time frame: Baseline, day 30
Saliva gamma-aminobutyric acid (GABA)
Time frame: Baseline, day 30
Saliva Orexin
Time frame: Baseline, day 30
Urine 6-sulfatoxymelatonin
Time frame: Baseline, day 30
Urine Norepinephrine
Time frame: Baseline, day 30
Actigraphy
Time frame: Baseline, day 30
Sleep Diary
Time frame: Baseline, day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl C Yang, doctor study chair
Institute of Brain Science ,National Yang Ming Chiao Tung University, Taipei City, Taiwan
1 site in 1 country: see every site and its status.
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.