A Probiotic That Improve Intestinal Flora

NCT ID: NCT06103240

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2022-06-11

Brief Summary

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

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.

Conditions

Intestinal Flora

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic group

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

Group Type: ACTIVE_COMPARATOR

Lacticaseibacillus rhamnosus LRa05

Intervention Type: OTHER

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

Placebo group

maltodextrin

Group Type: PLACEBO_COMPARATOR

Lacticaseibacillus rhamnosus LRa05

Intervention Type: OTHER

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

Interventions

Lacticaseibacillus rhamnosus LRa05

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan University of Technology

Zhengzhou, Henan, China

Countries

China

Other Identifiers

WK2023004

Identifier Type: -

Identifier Source: org_study_id