NCT06107049

the Effect of Probiotic on Sleep Quality Management

Probiotics Improve Sleep Quality: a Randomized Placebo-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Wecare Probiotics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

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".

Detailed description

Over the past few decades, the health benefits of probiotics have garnered extensive scientific attention. Particularly in the treatment of gastrointestinal and metabolic disorders, probiotics have shown potential therapeutic effects. The benefits of probiotics to the intestinal environment include improving intestinal barrier function, producing antimicrobial substances, competing with pathogenic bacteria, and regulating cavity acidity. However, research results on the benefits of probiotics for healthy adults are inconsistent. This may be due to variations in consumer sensitivity to the effects of probiotics and differences between probiotic products. The relationship between gut microbiota and human health has been widely recognized, especially in relation to diseases like obesity and diabetes. To verify the effects of the Bifidobacterium BLa80 product, a consumer test experiment was conducted, aiming to test and collect data on the changes in the gut microbiota of participants before and after using the product. The test plan lasted for 10 weeks, including a washout period at the beginning and end. During the experiment, participants consumed Bifidobacterium BLa80 and underwent multiple health checks and evaluations.

Conditions

• Poor Quality Sleep

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	BLa80	During the experiment, the subjects took a packet of probiotics every day, and the sleep condition, anxiety level and memory level of the subjects were evaluated by questionnaires and ability tests. The questionnaire included PSQI Pittsburgh Sleep Quality Index scale, ISI Insomnia Severity Index Scale and GSRS gastrointestinal symptom Score scale.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-03-30
• Completion: 2024-03-30
• First posted: 2023-10-30
• Last updated: 2024-04-26

Locations

1 site across 1 country: China