Status:
COMPLETED
Evaluating the Potential of Probiotic Supplementation Sleep Quality
Lead Sponsor:
Chi-Chang Huang
Collaborating Sponsors:
Bened Biomedical Co., Ltd.
Conditions:
Sleep Disorder
Anxiety
Eligibility:
All Genders
20-60 years
Phase:
NA
Brief 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 P...
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 adu...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06486064
Start Date
August 1 2024
End Date
December 30 2024
Last Update
July 20 2025
Active Locations (1)
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1
Graduate Institute of Sports Science, National Taiwan Sport University
Taoyuan District, Taiwan, 33301