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A Probiotic That Improve Intestinal Flora

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06103240
Enrollment
110
Registered
2023-10-26
Start date
2022-04-20
Completion date
2022-06-11
Last updated
2023-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Flora

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.

Interventions

OTHERLacticaseibacillus rhamnosus LRa05

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

Sponsors

Wecare Probiotics Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
intestinal flora test4 weeksSubjects 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026