InsomniaNCT04592276
The Effects of Lactobacillus Plantarum PS128 in Self-Reported Insomniacs
A study testing PS128 in people with Insomnia, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Insomnia
- What is being tested?
- PS128
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Oct 2018to 27 Dec 2019
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (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.
Who cannot join
- (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,
Show all 9Show fewer
- (7) inflammatory bowel disease,
- (8) hepatobiliary gastrointestinal tract surgery
- (9) worked the night shift.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Institute of Brain Science National Yang Ming University
Taipei, 112
About this study
Official title: The Effects of Lactobacillus Plantarum PS128 on Depression, Anxiety, Cerebral Rhythms, Autonomic Nervous System Function and Sleep Patterns in Self-Reported Insomniacs
To determine whether PS128 (1) reduces the severity of anxiety and depressive symptoms, (2) adjusts autonomic nervous system functioning, and (3) improves sleep quality.
Read the detailed description
Forty participants with self-reported insomnia between 20 and 40 years old were randomly assigned to two groups, the PS128 and a placebo group, under the double-blind trial. Participants took two capsules with or without PS128 after dinner for 30 days. Study measures included subjective depressive symptoms, anxiety and sleep questionnaires, and miniature polysomnography (miniature-PSG) recordings at baseline and on the 15th and 30th days after taking capsules.
- Conditions
- Insomnia
- Being tested
- PS128, placebo
- Keywords
- PS128, Anxiety, Depression, Electroencephalography
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS128Dietary supplement
Also called Lactobacillus plantarum
Participants took two capsules with PS128 after dinner for 30 days.
placeboDietary supplement
Participants took two capsules without PS128 after dinner for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| PS128 | Experimental | Each PS128 capsule contained 3 × 10^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg . Receives: Dietary Supplement: PS128 |
| placebo | Placebo comparator | The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The Beck Depression Inventory II (BDI-II) is a 21-item, self-rated scale 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, day15 and day30
Differences in the Beck Anxiety Inventory (BAI) before and after the consumption of probiotics compared to the placebo group.
the Beck Anxiety Inventory (BAI) is a 21-item, self-rated scale that evaluates anxiety levels , rated on a scale from 0 to 3. Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety.The maximum total score is 63.A higher score reflects greater anxiety.
Measured: Baseline, day15 and day30
Differences in The Pittsburgh Sleep Quality Index (PSQI) before and after the consumption of probiotics compared to the placebo group.
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.The maximum total score is 21. A higher score reflects more poor sleep quality.
Measured: baseline and day30
Differences in the Insomnia Severity Index (ISI) before and after the consumption of probiotics compared to the placebo group.
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 Likert-type 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, day15 and day30
Differences in the Epworth Sleepiness Scale (ESS) before and after the consumption of probiotics compared to the placebo group.
The Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of sleepiness. The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing.
Measured: Baseline, day15 and day30
Differences in heart rate variability (HRV) before and after the consumption of probiotics compared to the placebo group.
HRV is measured by the variatrasions in the R-R interval between the successive peaks of the QRS complex in the ECG wave. Based on fast Fourier transform, time-domain (R-R interval) transfer to frequency domain resulting total power (TP, 0.0-0.4), low frequency (LF, 0.04-0.15Hz), high frequency (HF, 0.15-0.4Hz), normalized LF (LF%) and LF/HF ratio are obtained. LF% and HF represent an index of sympathetic activity and parasympathetic activity respectively. LF/HF is indicative of the sympathetic to paympathetic autonomic balance.
Measured: Baseline, day15 and day30
Differences in Visual Analogue Scale (VAS) before and after the consumption of probiotics compared to the placebo group.
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, day15 and day30
Differences in the State and Trait Anxiety Index (STAI) before and after the consumption of probiotics compared to the placebo group.
The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. The score of state anxiety is from 0 to 80.The score of trait anxiety is from 0 to 80. Higher values represent a worse outcome.
Measured: Baseline, day15 and day30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start11 Oct 2018
- Primary completion27 Dec 2019
- Study completion27 Dec 2019
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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 University, Taipei City, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592276
- Sponsor's protocol ID
- YM107081E
- Status last verified
- Aug 2018
- First submitted
- 12 Oct 2020
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lactobacillus Plantarum PS128 on Depression, Anxiety, Cerebral Rhythms, Autonomic Nervous System Function and Sleep Patterns in Self-Reported Insomniacs
- ClinicalTrials.gov ID
- NCT04592276
- Acronym / sponsor ID
- YM107081E
- Conditions
- Insomnia
- Keywords
- PS128, Anxiety, Depression, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 19 Oct 2020 (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 PS128 (1) reduces the severity of anxiety and depressive symptoms, (2) adjusts autonomic nervous system functioning, and (3) improves sleep quality.
Detailed description
Forty participants with self-reported insomnia between 20 and 40 years old were randomly assigned to two groups, the PS128 and a placebo group, under the double-blind trial. Participants took two capsules with or without PS128 after dinner for 30 days. Study measures included subjective depressive symptoms, anxiety and sleep questionnaires, and miniature polysomnography (miniature-PSG) recordings at baseline and on the 15th and 30th days after taking capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PS128 | Experimental | Dietary Supplement: PS128Each PS128 capsule contained 3 × 10^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg . |
| placebo | Placebo comparator | Dietary Supplement: placeboThe placebo capsules only contained 425 ± 25 mg microcrystalline cellulose. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (9 listed)
- (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,
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 |
|---|---|---|
| PS128Also: Lactobacillus plantarumParticipants took two capsules with PS128 after dinner for 30 days. | Dietary supplement | PS128 |
| placeboParticipants took two capsules without PS128 after dinner for 30 days. | Dietary supplement | placebo |
Primary outcome
Differences in sleep EEG before and after the consumption of probiotics compared to the placebo group.
Time frame: Baseline, day15 and day30
According to sleep EEG,we can analysis participants' brain waves (alpha,beta,theta,delta) and sleep stages,etc. to evaluate their objective sleep quality.
8 secondary outcomes
Differences in The Beck Depression Inventory II (BDI-II) before and after the consumption of probiotics compared to the placebo group.
Time frame: Baseline, day15 and day30
Differences in the Beck Anxiety Inventory (BAI) before and after the consumption of probiotics compared to the placebo group.
Time frame: Baseline, day15 and day30
Differences in The Pittsburgh Sleep Quality Index (PSQI) before and after the consumption of probiotics compared to the placebo group.
Time frame: baseline and day30
Differences in the Insomnia Severity Index (ISI) before and after the consumption of probiotics compared to the placebo group.
Time frame: Baseline, day15 and day30
Differences in the Epworth Sleepiness Scale (ESS) before and after the consumption of probiotics compared to the placebo group.
Time frame: Baseline, day15 and day30
Differences in heart rate variability (HRV) before and after the consumption of probiotics compared to the placebo group.
Time frame: Baseline, day15 and day30
Differences in Visual Analogue Scale (VAS) before and after the consumption of probiotics compared to the placebo group.
Time frame: Baseline, day15 and day30
Differences in the State and Trait Anxiety Index (STAI) before and after the consumption of probiotics compared to the placebo group.
Time frame: Baseline, day15 and day30
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 21 Jul 2022.
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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 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 PS128 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 5 inclusion and 9 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 21 Jul 2022. 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?
Differences in sleep EEG before and after the consumption of probiotics compared to the placebo group. (time frame: Baseline, day15 and 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 21 Jul 2022.