A Probiotic That Improve Intestinal Flora

Study Overview
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Brief Summary
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Purpose: to verify the physiological properties of Lactobacillus rhamnosus LRa05. Bacterial count:100 billion Test Objective: to test and collect the changes of intestinal flora before and after the daily use of LRa05 product.

Detailed Description
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In order to validate the physiological properties of the 100 billion probiotic Lactobacillus rhamnosus LRa05 product and to gather sufficient evidence to test the changes in the intestinal flora before and after the daily use of the probiotic product, the test was conducted on 110 college students aged 18-25 years. The primary outcome was to investigate the increase in the diversity of the gut flora and the increase in the peak levels of beneficial bacteria in the gut, and the secondary outcome was to investigate whether there was a significant improvement in the PSQI Pittsburgh Sleep Quality Index and the ISI Insomnia Severity Index.

Official Title
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Changes in the Gut Microbiota Composition of Healthy Young Volunteers After Administration of Lacticaseibacillus Rhamnosus LRa05: A Placebo-controlled Study

Conditions
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Intestinal Flora

Intervention / Treatment
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* Other: Lacticaseibacillus rhamnosus LRa05


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PSQI Pittsburgh Sleep Quality Index scale score >6 and <18 ISI Insomnia Severity Index scale score >8 and <23 Exclusion Criteria: People who have been diagnosed with diabetes or have high blood sugar are not recommended to participate in the test; people whose daily diet is too light or too oily are not recommended to participate in the test; people with special dietary structure (e.g. ketogenic diet, etc.) caused by weight loss or other reasons, such as muscle gain and fat loss, are not recommended to participate in the test; others with special conditions are not recommended to participate, such as those who are allergic to probiotic products; pregnant women, lactating women and people under 19 and over 45 years old should not experiment; people with unhealthy stomach and intestines are not recommended to participate in the test; people with low body fat and BMI <23 are not recommended to participate in the test.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic group<br>Bacterial count：100 billion CFUs Take one sachet per day for 4 weeks. | Other: Lacticaseibacillus rhamnosus LRa05<br>* Bacterial count:100 billion CFUs Take one sachet per day for 4 weeks.<br>|
| Placebo Comparator: Placebo group<br>maltodextrin | Other: Lacticaseibacillus rhamnosus LRa05<br>* Bacterial count:100 billion CFUs Take one sachet per day for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intestinal flora test | Subjects took a packet of probiotics every day. Before taking probiotics, two weeks after taking probiotics, and after taking probiotics, fecal samples were collected, and fecal 16s rRNA was extracted using a DNA kit. | 4 weeks |