Sleep DisorderNCT06486064
Evaluating the Potential of Probiotic Supplementation Sleep Quality
A study testing heat-treated Limosilactobacillus fermentum in people with Sleep Disorder and Anxiety, run by Chi-Chang Huang at 1 site in Taiwan.
Trial summary
This study aims to evaluate the feasibility of probiotics in improving sleep indicators through clinical human studies. Previous animal experiments have confirmed that Limosilactob acillus fermentum PS150 and heat-treated Lactobacillus fermentum HT-PS150 strains have the effect of improving sleep. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Sleep Disorder, Anxiety, Depression
- What is being tested?
- heat-treated Limosilactobacillus fermentum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2024to 30 Dec 2024
- 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
- Age 20 to 60 years old
- Pittsburgh Sleep Quality Scale score is greater than or equal to 5
- Insomnia Severity Scale (ISI less than 22 points)
- Subjects need to have a regular daily routine (no night shift work)
Who cannot join
- Have used antibiotics or probiotic products in powder, capsule or tablet form within one month
- Are taking drugs that may affect sleep (for example: sleeping pills, antipsychotic drugs, corticosteroids, antihistamines, stimulants, etc.) or undergoing hormonal treatment (including birth control pills)
- Those who are taking traditional Chinese medicine or western medicine to treat serious acute diseases
- Patients with uncontrolled high blood pressure or diabetes, a history of cancer, and mental illness
- Those with a diagnosis of other sleep disorders besides insomnia (narcolepsy, restless legs, sleep apnea, etc.)
- People who are allergic to probiotic products
Show all 11Show fewer
- Pregnant or breastfeeding
- Alcohol, tobacco and coffee addicts
- Have carried out long-distance travel or work across time zones in the past month and the next two months
- Those who have participated in other interventional clinical studies in the past three months
- Those who are judged by the moderator to be unsuitable to participate in the research
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Graduate Institute of Sports Science, National Taiwan Sport University
Taoyuan, 33301
About this study
This study aims to evaluate the feasibility of probiotics in improving sleep indicators through clinical human studies. Previous animal experiments have confirmed that Limosilactob acillus fermentum PS150 and heat-treated Lactobacillus fermentum HT-PS150 strains have the effect of improving sleep. 90 subjects will be recruited, 45 in each group. They will be given either HT-PS150 or placebo for 8 weeks and their blood, urine, saliva and questionnaire will be evaluated.
Read the detailed description
The most important function of sleep is to restore physical energy lost after activities during the day, and to adjust and reorganize people's emotions, behavior, and cognitive memory. The average adult sleeps about 7 to 8 hours. Good sleep quality has a great impact on the performance of work and study during the day. If a person does not get enough sleep for a long time, it is easy to suffer from memory loss, emotional instability and other phenomena. It will also affect the operation of the immune system and easily lead to colds and illnesses. The following statements are often complained by sleep disorder patient: 1. Difficulty falling asleep. 2. Difficulty maintaining sleep, often waking up suddenly in the middle of sleep or having difficulty falling back to sleep once woken up. 3. Waking up too early and having trouble falling back to sleep. This study aims to evaluate the feasibility of probiotics in improving sleep indicators through clinical human studies. Previous animal experiments have confirmed that Limosilactob acillus fermentum PS150 and heat-treated Lactobacillus fermentum HT-PS150 strains have the effect of improving sleep.
- Conditions
- Sleep Disorder, Anxiety, Depression, Stress, Probiotics
- Being tested
- heat-treated Limosilactobacillus fermentum, Placebo
- Medical subject headings
- Sleep Wake Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heat-treated Limosilactobacillus fermentumDietary supplement
Also called HT-PS150
one capsule daily for 8 weeks
PlaceboDietary supplement
one capsule daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| probiotics | Experimental | heat-treated Limosilactobacillus fermentum PS150 Receives: Dietary Supplement: heat-treated Limosilactobacillus fermentum |
| placebo | Placebo comparator | microcrystalline cellulose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh sleep quality index, PSQI
The Pittsburgh Sleep Quality Index contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
Measured: From baseline to 8 weeks assessed
Insomnia severity index, ISI
The ISI is a 7-item patient-reported outcome measure (PROM) assessing the nature, severity, and impact of insomnia on a 5-point Likert scale to rate each item from 0 (no problem) to 4 (very severe problem).
Measured: From baseline to 8 weeks assessed
Secondary outcomes (17)
Total sleep time
Compare the sleep times on the Fitbit
Measured: From one week before baseline to 8 weeks assessed
Change in Generalised Anxiety Disorder Assessment (GAD-7)
The Generalised Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day"
Measured: From baseline to 8 weeks assessed
Change in Depression Score Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression: The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool.Depression Severity: 0- none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Validity has been assessed against an independent structured mental health professional (MHP) interview. PHQ-9 score ≥10 had a sensitivity of 88% and a specificity of 88% for major depression.
Measured: From baseline to 8 weeks assessed
Change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 is a valid, reliable self-report instrument for assessing quality of life. The minimum raw score on the Q-LES-Q-16 is 14, and the maximum score is 70, higher scores mean a better outcome.
Measured: From baseline to 8 weeks assessed
Change in Visual Analogue Scale-GI (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 patients after taking probiotics or placebo.
Measured: From baseline to 8 weeks assessed
Patient Global Impression scales of Improvement rated by patient（PGI-C）
The PGIC consists of one item taken from the clinical global impression and adapted to the patient. The minimum total score possible is 1 and the maximum total score possible is 7. Higher values represent a worse outcome.
Measured: From baseline to 8 weeks assessed
Change in Melatonin in both blood and saliva
Measured: From baseline to 8 weeks assessed
Change in Cortisol in both blood and saliva
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 body's metabolism of glucose control 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 body to ensure the balance is correct.
Measured: From baseline to 8 weeks assessed
Change in Total Antioxidant Capacity , TAC
Levels of Total Antioxidant Capacity , TAC in serum
Measured: From baseline to 8 weeks assessed
Change in GABA in both blood and saliva
GABA is known for producing a calming effect. It's thought to play a major role in controlling nerve cell hyperactivity associated with anxiety, stress and fear.
Measured: From baseline to 8 weeks assessed
Change in Serotonin in both blood and saliva
Serotonin is a chemical that carries messages between nerve cells in the brain and throughout your body. Serotonin plays a key role in such body functions as mood, sleep, digestion, nausea, wound healing, bone health, blood clotting and sexual desire. Serotonin levels that are too low or too high can cause physical and psychological health problems.
Measured: From baseline to 8 weeks assessed
Change in Orexin in both blood and saliva
Orexin
Measured: From baseline to 8 weeks assessed
Change in 6 sulfatoxymelatonin in urine
6 sulfatoxymelatonin
Measured: From baseline to 8 weeks assessed
Change in Norepinephrine in both blood and urine
Norepinephrine
Measured: From baseline to 8 weeks assessed
Changes in Interleukin-6 (IL-6) in saliva
changes in IL-6 blood serum concentration levels in serum experimental group (in comparison to placebo control)
Measured: From baseline to 8 weeks assessed
Change in Gut microbiome
The gut microbiome plays important roles in both the maintenance of health and the pathogenesis of disease. Stool will be examined before and after probiotics.
Measured: From baseline to 8 weeks assessed
Sleep quality
Compare the sleep score recorded on the Fitbit
Measured: From baseline to 8 weeks assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Aug 2024
- Primary completion30 Oct 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chi-Chang Huang
- Sponsor type
- University, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Responsible party
- Sponsor-investigator, Chi-Chang Huang, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486064
- Sponsor's protocol ID
- B032
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2024
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Potential of Probiotic Supplementation Sleep Quality
- ClinicalTrials.gov ID
- NCT06486064
- Acronym / sponsor ID
- B032
- Conditions
- Sleep Disorder, Anxiety, Depression, Stress, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Chi-Chang HuangUniversity, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 3 Jul 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.
This study aims to evaluate the feasibility of probiotics in improving sleep indicators through clinical human studies. Previous animal experiments have confirmed that Limosilactob acillus fermentum PS150 and heat-treated Lactobacillus fermentum HT-PS150 strains have the effect of improving sleep. 90 subjects will be recruited, 45 in each group. They will be given either HT-PS150 or placebo for 8 weeks and their blood, urine, saliva and questionnaire will be evaluated.
Detailed description
The most important function of sleep is to restore physical energy lost after activities during the day, and to adjust and reorganize people's emotions, behavior, and cognitive memory. The average adult sleeps about 7 to 8 hours. Good sleep quality has a great impact on the performance of work and study during the day. If a person does not get enough sleep for a long time, it is easy to suffer from memory loss, emotional instability and other phenomena. It will also affect the operation of the immune system and easily lead to colds and illnesses. The following statements are often complained by sleep disorder patient: 1. Difficulty falling asleep. 2. Difficulty maintaining sleep, often waking up suddenly in the middle of sleep or having difficulty falling back to sleep once woken up. 3. Waking up too early and having trouble falling back to sleep. This study aims to evaluate the feasibility of probiotics in improving sleep indicators through clinical human studies. Previous animal experiments have confirmed that Limosilactob acillus fermentum PS150 and heat-treated Lactobacillus fermentum HT-PS150 strains have the effect of improving sleep.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotics | Experimental | Dietary Supplement: heat-treated Limosilactobacillus fermentumheat-treated Limosilactobacillus fermentum PS150 |
| placebo | Placebo comparator | Dietary Supplement: Placebomicrocrystalline cellulose |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20 to 60 years old
- Pittsburgh Sleep Quality Scale score is greater than or equal to 5
- Insomnia Severity Scale (ISI less than 22 points)
- Subjects need to have a regular daily routine (no night shift work)
Key exclusion criteria (11 listed)
- Have used antibiotics or probiotic products in powder, capsule or tablet form within one month
- Are taking drugs that may affect sleep (for example: sleeping pills, antipsychotic drugs, corticosteroids, antihistamines, stimulants, etc.) or undergoing hormonal treatment (including birth control pills)
- Those who are taking traditional Chinese medicine or western medicine to treat serious acute diseases
- Patients with uncontrolled high blood pressure or diabetes, a history of cancer, and mental illness
- Those with a diagnosis of other sleep disorders besides insomnia (narcolepsy, restless legs, sleep apnea, etc.)
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 |
|---|---|---|
| heat-treated Limosilactobacillus fermentumAlso: HT-PS150one capsule daily for 8 weeks | Dietary supplement | probiotics |
| Placeboone capsule daily for 8 weeks | Dietary supplement | placebo |
Primary outcome
Pittsburgh sleep quality index, PSQI
Time frame: From baseline to 8 weeks assessed
The Pittsburgh Sleep Quality Index contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
Insomnia severity index, ISI
Time frame: From baseline to 8 weeks assessed
The ISI is a 7-item patient-reported outcome measure (PROM) assessing the nature, severity, and impact of insomnia on a 5-point Likert scale to rate each item from 0 (no problem) to 4 (very severe problem).
17 secondary outcomes
Total sleep time
Time frame: From one week before baseline to 8 weeks assessed
Change in Generalised Anxiety Disorder Assessment (GAD-7)
Time frame: From baseline to 8 weeks assessed
Change in Depression Score Patient Health Questionnaire (PHQ-9)
Time frame: From baseline to 8 weeks assessed
Change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16
Time frame: From baseline to 8 weeks assessed
Change in Visual Analogue Scale-GI (VAS-GI)
Time frame: From baseline to 8 weeks assessed
Patient Global Impression scales of Improvement rated by patient（PGI-C）
Time frame: From baseline to 8 weeks assessed
Change in Melatonin in both blood and saliva
Time frame: From baseline to 8 weeks assessed
Change in Cortisol in both blood and saliva
Time frame: From baseline to 8 weeks assessed
Change in Total Antioxidant Capacity , TAC
Time frame: From baseline to 8 weeks assessed
Change in GABA in both blood and saliva
Time frame: From baseline to 8 weeks assessed
Change in Serotonin in both blood and saliva
Time frame: From baseline to 8 weeks assessed
Change in Orexin in both blood and saliva
Time frame: From baseline to 8 weeks assessed
Change in 6 sulfatoxymelatonin in urine
Time frame: From baseline to 8 weeks assessed
Change in Norepinephrine in both blood and urine
Time frame: From baseline to 8 weeks assessed
Changes in Interleukin-6 (IL-6) in saliva
Time frame: From baseline to 8 weeks assessed
Change in Gut microbiome
Time frame: From baseline to 8 weeks assessed
Sleep quality
Time frame: From baseline to 8 weeks assessed
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 20 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heat-treated Limosilactobacillus fermentum in people with Sleep Disorder and Anxiety, run by Chi-Chang Huang 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 11 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 20 Jul 2025. 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?
Pittsburgh sleep quality index, PSQI (time frame: From baseline to 8 weeks assessed). The study lists 2 primary outcomes in all. 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 20 Jul 2025.