Healthy AdultsNCT06875362
Probiotic LR08 Improves Gut and Metabolism
A study testing Probiotic in people with Healthy Adults, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
Evaluate the efficacy and safety of LR08 as a dietary supplement compared to a placebo in enhancing intestinal health and immune function in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2025to 30 Jun 2025
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to attend 3 follow-up visits during the intervention period
- Agree to provide blood, urine, and stool samples twice during the intervention period
- Good eyesight, able to read and write, and capable of wearing glasses if needed
- Good hearing and able to fully comprehend all instructions during the intervention
Who cannot join
- Presence of digestive diseases, particularly gastrointestinal disorders (e.g., celiac disease, ulcerative colitis, Crohn's disease)
- History of serious neurological conditions (e.g., epilepsy, stroke, severe head trauma, meningitis within the last 10 years, brain surgery, brain tumor, or prolonged coma-not including general anesthesia)
- History of or currently receiving treatment for mental health disorders such as alcohol/drug/substance abuse, schizophrenia, psychosis, or bipolar disorder
- Currently taking medication for depression or low mood
- Presence of internal organ failure (e.g., heart, liver, or kidney failure)
- History of radiation therapy or chemotherapy treatments
- Underwent general anesthesia within the past three years or are scheduled for general anesthesia within the next 3 months during the trial period
- History of hepatitis (B or C), HIV, or syphilis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of LR08 in Modulating Gut Microbiota and Improving Metabolic Health in Healthy Adults: A Clinical Study
Evaluate the efficacy and safety of LR08 as a dietary supplement compared to a placebo in enhancing intestinal health and immune function in healthy adults.
- Conditions
- Healthy Adults
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotics, Efficacy, Safety, Gut Microbiota, Immune Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The trial period of this study lasts for 2 months(8weeks), during which each participant will have 3 visits (at month 0, month 1, andmonth 2).
PlaceboDietary supplement
The trial period of this study lasts for 2 months(8weeks), during which each participant will have 3 visits (at month 0, month 1, andmonth 2).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | Intervention with probiotic LR08 (30 billion CFU/day, 3g) was administered daily for 8 weeks. Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | Every day to give 3 g maltodextrin intervention for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Immune Function
Evaluation of immune function markers, specifically immunoglobulin A (IgA) concentration, to assess the effects of LR08 supplementation compared to placebo.
Measured: Week 0 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start10 Mar 2025
- Primary completion30 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies 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
- 48 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
- NCT06875362
- Sponsor's protocol ID
- WK20250308
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Han M, Xu F, Dong Y, Zhu J, Fang S, Zhao L. Safety and immune-regulating effects of Limosilactobacillus reuteri LR08: Preclinical and clinical evidence from a randomized controlled trial. Clin Nutr. 2026 Mar;58:106582. doi: 10.1016/j.clnu.2026.106582. Epub 2026 Jan 20.
PubMed 41650801
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of LR08 in Modulating Gut Microbiota and Improving Metabolic Health in Healthy Adults: A Clinical Study
- ClinicalTrials.gov ID
- NCT06875362
- Acronym / sponsor ID
- WK20250308
- Conditions
- Healthy Adults
- Keywords
- Probiotics, Efficacy, Safety, Gut Microbiota, Immune Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 13 Mar 2025 (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.
Evaluate the efficacy and safety of LR08 as a dietary supplement compared to a placebo in enhancing intestinal health and immune function in healthy adults.
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 | Dietary Supplement: ProbioticIntervention with probiotic LR08 (30 billion CFU/day, 3g) was administered daily for 8 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboEvery day to give 3 g maltodextrin intervention for 8 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Willing to attend 3 follow-up visits during the intervention period
- Agree to provide blood, urine, and stool samples twice during the intervention period
- Good eyesight, able to read and write, and capable of wearing glasses if needed
- Good hearing and able to fully comprehend all instructions during the intervention
Key exclusion criteria (8 listed)
- Presence of digestive diseases, particularly gastrointestinal disorders (e.g., celiac disease, ulcerative colitis, Crohn's disease)
- History of serious neurological conditions (e.g., epilepsy, stroke, severe head trauma, meningitis within the last 10 years, brain surgery, brain tumor, or prolonged coma-not including general anesthesia)
- History of or currently receiving treatment for mental health disorders such as alcohol/drug/substance abuse, schizophrenia, psychosis, or bipolar disorder
- Currently taking medication for depression or low mood
- Presence of internal organ failure (e.g., heart, liver, or kidney failure)
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 |
|---|---|---|
| ProbioticThe trial period of this study lasts for 2 months(8weeks), during which each participant will have 3 visits (at month 0, month 1, andmonth 2). | Dietary supplement | Probiotic group |
| PlaceboThe trial period of this study lasts for 2 months(8weeks), during which each participant will have 3 visits (at month 0, month 1, andmonth 2). | Dietary supplement | Placebo group |
Primary outcome
Changes in Immune Function
Time frame: Week 0 and Week 8
Evaluation of immune function markers, specifically immunoglobulin A (IgA) concentration, to assess the effects of LR08 supplementation compared to placebo.
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 1 Aug 2025.
- Derived from this study: PubMed 41650801Han M, Xu F, Dong Y, Zhu J, Fang S, Zhao L. Safety and immune-regulating effects of Limosilactobacillus reuteri LR08: Preclinical and clinical evidence from a randomized controlled trial. Clin Nutr. 2026 Mar;58:106582. doi: 10.1016/j.clnu.2026.106582. Epub 2026 Jan 20.
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Healthy Participants
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 Probiotic in people with Healthy Adults, 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 4 inclusion and 8 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 1 Aug 2025. 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?
Changes in Immune Function (time frame: Week 0 and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06875362, which also lists 1 linked publication.
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 1 Aug 2025.