Poor Quality Sleep Clinical Trial
Official title:
Probiotics Improve Sleep Quality: a Randomized Placebo-controlled Trial
Verified date | April 2024 |
Source | Wecare Probiotics Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical trial is to learn about the improvement of sleep quality of probiotic BLa 80 in 110 healthy college students. The main question it aims to answer is whether probiotic BLa80 can effectively improve the sleep quality of college students. The experiment commenced with participants continuously consuming the recommended amount of the probiotic powder for approximately 8 weeks. Simultaneously, they were required to fill out an "Effect Evaluation Form" every week and submit it to relevant department. At the end of the first and eighth weeks, participants underwent tests for five liver functions, four lipid profiles, blood sugar, and uric acid levels, as well as stool sample collection. They then completed the "Mid-Term Effect Evaluation Form".
Status | Completed |
Enrollment | 110 |
Est. completion date | March 30, 2024 |
Est. primary completion date | March 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: - PSQI Pittsburgh Sleep Quality Index score > 6 and < 18; - ISI insomnia Severity Index score > 8 and < 23. Exclusion Criteria: - Those who have been diagnosed with diabetes or have high blood sugar are not recommended to participate in the test; - Mental or nervous system diseases, celiac disease, lactose intolerance, allergy; - Have the following diseases: irritable bowel syndrome, diabetes, ulcerative colitis, etc.; - Recent antibiotic treatment (i.e. < 3 months before study start); - Participants who smoked more than 10 cigarettes per day were excluded; - Other people with special circumstances are not recommended to participate, such as those who are allergic to probiotic products; - Pregnant women, breastfeeding women and people under 19 years old and over 45 years old should not be tested. |
Country | Name | City | State |
---|---|---|---|
China | Henan University of Technology | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Wecare Probiotics Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in sleep quality | ISI insomnia Severity Index Scale questionnaire(It is divided into 7 items, with a total score of 28 points. 0 to 7 is divided into clinically insignificant insomnia, 8 to 14 is divided into mild insomnia, 15 to 21 is divided into moderate insomnia, and 22 to 28 is divided into severe insomnia.) | 8 weeks |
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