Intestinal FloraNCT06103240
A Probiotic That Improve Intestinal Flora
A study testing Lacticaseibacillus rhamnosus LRa05 in people with Intestinal Flora, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Flora
- What is being tested?
- Lacticaseibacillus rhamnosus LRa05
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2022to 11 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- PSQI Pittsburgh Sleep Quality Index scale score >6 and <18
- ISI Insomnia Severity Index scale score >8 and <23
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in the Gut Microbiota Composition of Healthy Young Volunteers After Administration of Lacticaseibacillus Rhamnosus LRa05: A Placebo-controlled Study
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.
Read the 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
- Being tested
- Lacticaseibacillus rhamnosus LRa05
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacticaseibacillus rhamnosus LRa05Other
Bacterial count:100 billion CFUs Take one sachet per day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | Bacterial count：100 billion CFUs Take one sachet per day for 4 weeks. Receives: Other: Lacticaseibacillus rhamnosus LRa05 |
| Placebo group | Placebo comparator | maltodextrin Receives: Other: Lacticaseibacillus rhamnosus LRa05 |
What is being measured
The primary outcome is the main question the study is designed to answer.
intestinal flora test
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start20 Apr 2022
- Primary completion25 Apr 2022
- Study completion11 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal FloraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103240
- Sponsor's protocol ID
- WK2023004
- Status last verified
- Oct 2023
- First submitted
- 21 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Gut Microbiota Composition of Healthy Young Volunteers After Administration of Lacticaseibacillus Rhamnosus LRa05: A Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06103240
- Acronym / sponsor ID
- WK2023004
- Conditions
- Intestinal Flora
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 11 Jun 2022 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Active comparator | Other: Lacticaseibacillus rhamnosus LRa05Bacterial count：100 billion CFUs Take one sachet per day for 4 weeks. |
| Placebo group | Placebo comparator | Other: Lacticaseibacillus rhamnosus LRa05maltodextrin |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- PSQI Pittsburgh Sleep Quality Index scale score >6 and <18
- ISI Insomnia Severity Index scale score >8 and <23
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacticaseibacillus rhamnosus LRa05Bacterial count:100 billion CFUs Take one sachet per day for 4 weeks. | Other | Placebo group, Probiotic group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lacticaseibacillus rhamnosus LRa05 in people with Intestinal Flora, run by Wecare Probiotics Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intestinal flora test (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.