- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06361368
Efficacy Assessment of Probiotics in Improving Sleep Indices
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yu En Kuo, Master
- Phone Number: +886 975231262
- Email: iankuo1106@gmail.com
Study Contact Backup
- Name: Cheryl C Yang, doctor
- Email: cchyang@gmail.com
Study Locations
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Taipei, Taiwan, 112304
- Institute of Brain Science National Yang Ming Chiao Tung University
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Contact:
- Yu En Kuo, Master
- Phone Number: +886 975231262
- Email: iankuo1106@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 20-60 years old,
- self-reported Insomnia (PSQI ≥ 7 & 22 > ISI ≥ 12),
- 17.5 < BMI < 35 kg/m^2, and
- regular sleep cycle.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: PS150
Each PS150 (Limosilactobacillus fermentum) capsule contained 5 × 10^9 colony forming units (CFU) , 1 caupsule daily use.
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Participants took one capsule with PS150 after dinner for 30 days.
Other Names:
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Placebo Comparator: Placebo
The placebo capsule contains microcrystalline cellulose, 1 capsule daily use.
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Participants took one capsule with placebo after dinner for 30 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Polysomnography (PSG)
Time Frame: Baseline, day30
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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.
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Baseline, day30
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, day 30
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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.
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Baseline, day 30
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Insomnia Severity Index (ISI)
Time Frame: Baseline, day 30
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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.
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Baseline, day 30
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Beck Depression Inventory-Second Edition (BDI-II)
Time Frame: Baseline, day 30
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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.
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Baseline, day 30
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Beck Anxiety Inventory (BAI)
Time Frame: Baseline, day 30
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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.
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Baseline, day 30
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VAS-Sleep
Time Frame: Baseline, day 30
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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).
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Baseline, day 30
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Epworth Sleepiness Scale (ESS)
Time Frame: Baseline, day 30
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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.
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Baseline, day 30
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Standford Sleepiness Scale (SSS)
Time Frame: Baseline, day 30
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The Stanford Sleepiness Scale (SSS) is a 7-point Likert inventory to evaluate a respondent's sleepiness at the time when it is completed.
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Baseline, day 30
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Visual Analogue Scale for gastrointestinal symptoms (VAS-GI)
Time Frame: Baseline, day 30
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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.
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Baseline, day 30
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Saliva Melatonin
Time Frame: Baseline, day 30
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pg/ml of melatonin in saliva measured by enzyme-linked immunosorbent assay.
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Baseline, day 30
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Saliva Cortisol
Time Frame: Baseline, day 30
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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. |
Baseline, day 30
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Saliva IL-6
Time Frame: Baseline, day 30
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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 - 80C.
Enzyme-linked immunosorbent assays were used to quantify IL-6 amount (ng/mL).
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Baseline, day 30
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Saliva Total Antioxidant Capacity (TAC)
Time Frame: Baseline, day 30
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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 - 80C.
Enzyme-linked immunosorbent assays were used to quantify TAC amount (nmol/mL).
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Baseline, day 30
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Saliva Serotonin
Time Frame: Baseline, day 30
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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 - 80C.
Enzyme-linked immunosorbent assays were used to quantify serotonin amount (ng/mL).
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Baseline, day 30
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Saliva GABA
Time Frame: Baseline, day 30
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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 - 80C.
Enzyme-linked immunosorbent assays were used to quantify GABA amount (pg/mL).
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Baseline, day 30
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Saliva Orexin
Time Frame: Baseline, day 30
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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 - 80C.
Enzyme-linked immunosorbent assays were used to quantify Orexin amount.
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Baseline, day 30
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Urine 6-sulfatoxymelatonin
Time Frame: Baseline, day 30
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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 HCl and stored at -80 degrees for analysis in the biochemistry laboratory.
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Baseline, day 30
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Urine Norepinephrine
Time Frame: Baseline, day 30
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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 HCl and stored at -80 degrees for analysis in the biochemistry laboratory.
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Baseline, day 30
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Actigraphy
Time Frame: Baseline, day 30
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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. |
Baseline, day 30
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Sleep Diary
Time Frame: Baseline, day 30
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The sleep diary is a daily self-reported 12-item form within 30 minutes after wake up.
It assesses respondant's time taken to fall asleep (sleep onset latency), wake after sleep onset, total sleep, total time in bed, and sleep efficiency, etc.
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Baseline, day 30
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Cheryl C Yang, doctor, Institute of Brain Science ,National Yang Ming Chiao Tung University, Taipei City, Taiwan
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NYCU112174AF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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