A Probiotic That Improve Intestinal Flora

Wecare Probiotics

Status: Completed

Conditions: Intestinal Flora

Treatments: Other: Lacticaseibacillus rhamnosus LRa05

Study type: Interventional

Funder types: Industry

Identifiers

NCT06103240

WK2023004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. PSQI Pittsburgh Sleep Quality Index scale score >6 and <18
2. ISI Insomnia Severity Index scale score >8 and <23

Exclusion criteria

1. People who have been diagnosed with diabetes or have high blood sugar are not recommended to participate in the test;
2. 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;
3. others with special conditions are not recommended to participate, such as those who are allergic to probiotic products;
4. pregnant women, lactating women and people under 19 and over 45 years old should not experiment;
5. people with unhealthy stomach and intestines are not recommended to participate in the test;
6. people with low body fat and BMI <23 are not recommended to participate in the test.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

Probiotic group

Active Comparator group

Description:

Bacterial count：100 billion CFUs Take one sachet per day for 4 weeks.

Treatment:

Other: Lacticaseibacillus rhamnosus LRa05

Placebo group

Placebo Comparator group

Description:

maltodextrin

Treatment:

Other: Lacticaseibacillus rhamnosus LRa05