A Probiotic That Improve Intestinal Flora

Not Applicable

Completed

• Conditions: Intestinal Flora
• Interventions: Other: Lacticaseibacillus rhamnosus LRa05

• Registration Number: NCT06103240
• Lead Sponsor: Wecare Probiotics Co., Ltd.

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.

Study Timeline

• Study Start: 2022-04-20
• Primary Completion: 2022-04-25
• Study Completion: 2022-06-11
• Status Verified: 2023-10
• Study First Submitted: 2023-10-21
• Study First Submitted QC: 2023-10-21
• Last Update Submitted: 2023-10-21
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic group	Lacticaseibacillus rhamnosus LRa05	Bacterial count：100 billion CFUs Take one sachet per day for 4 weeks.
Placebo group	Lacticaseibacillus rhamnosus LRa05	maltodextrin

Primary Outcome Measures

Name	Time	Method
intestinal flora test	4 weeks	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.

Trial Locations

Locations (1)

Henan University of Technology; 🇨🇳 Zhengzhou, Henan, China