Efficacy Assessment of Probiotics in Improving Sleep Indices
NCT ID: NCT06361368
Last Updated: 2024-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2024-04-11
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PS150
Each PS150 (Limosilactobacillus fermentum) capsule contained 5 × 10\^9 colony forming units (CFU) , 1 capsule daily use.
PS150
Participants took one capsule with PS150 after dinner for 30 days.
Placebo
The placebo capsule contains microcrystalline cellulose, 1 capsule daily use.
Placebo
Participants took one capsule with placebo after dinner for 30 days.
Interventions
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PS150
Participants took one capsule with PS150 after dinner for 30 days.
Placebo
Participants took one capsule with placebo after dinner for 30 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. self-reported Insomnia (PSQI ≥ 7 \& 22 \> ISI ≥ 12),
3. 17.5 \< BMI \< 35 kg/m\^2, and
4. regular sleep cycle.
Exclusion Criteria
2. used other probiotic products within the last month,
3. taking medications known to commonly induce sleep disorders (such as corticosteroids, antihistamines, and stimulants, etc.) or currently undergoing hormone therapy, including contraceptive pills,
4. have undergone hepatobiliary gastrointestinal tract surgery
5. lactic acid bacteria allergy,
6. with cancer, cardiovascular disease, psychiatric illness, or kidney disease,
7. with uncontrolled diabetes mellitus or hypertension,
8. with sleep disorders other than insomnia,
9. allergic to lactobacillus,
10. reported tobacco, alcohol, caffeine or drug addiction,
11. traveled to different time zone in long-distance trip within the last month,
12. participated in other interventional studies within the last three months, and
13. evaluated as unsuitable participant by PI.
20 Years
60 Years
ALL
No
Sponsors
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Bened Biomedical Co., Ltd.
INDUSTRY
National Yang Ming Chiao Tung University
OTHER
Responsible Party
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Principal Investigators
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Cheryl C Yang, doctor
Role: STUDY_CHAIR
Institute of Brain Science ,National Yang Ming Chiao Tung University, Taipei City, Taiwan
Locations
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Institute of Brain Science National Yang Ming Chiao Tung University
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NYCU112174AF
Identifier Type: -
Identifier Source: org_study_id
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