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OpenTrials
Completed

NCT Number: NCT06103240

A Probiotic That Improve Intestinal Flora

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.

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Key information

Conditions

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henan University of Technology

Zhengzhou, Henan, 450001, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lacticaseibacillus rhamnosus LRa05

Other

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

Primary outcomes

  1. intestinal flora test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2023
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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