Gut Microbiota ModulationNCT06875375
The Role of Probiotic LH76 in Human Gut Health
A study testing probiotic LH76 in people with Gut Microbiota Modulation, run by Wecare Probiotics Co., Ltd..
Trial summary
This study aims to evaluate the safety and efficacy of the probiotic LH76 as a dietary supplement in healthy adults. The research will assess its effects on gut microbiota composition, intestinal health, and immune function compared to a placebo. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota Modulation
- What is being tested?
- probiotic LH76
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2025to 26 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 undergo 3 follow-up visits during the intervention period Be willing to provide blood, urine and stool samples 2 times during the intervention period
- Willing to self-administer probiotic or placebo once a day during the intervention period
- Good eyesight, can read and write, can wear glasses
- Have good hearing and be able to hear and understand all instructions during the intervention
Who cannot join
- Digestive diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease)
- Have a serious neurological condition (epilepsy, stroke, severe head trauma, meningitis in the last 10 years, brain surgery, brain tumor, prolonged coma - not including general anaesthesia)
- Have received/are receiving treatment for the following mental disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
- Take medication for depression or low mood Internal organ failure (heart, liver or kidney failure, etc.)
- Have received radiation or chemotherapy in the past
- Have undergone a general anesthesia procedure/procedure within the past three years, or plan to undergo a general anesthesia procedure/procedure within the next 3 months during this trial period
- Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past Open Contacts/Locations
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study on the Safety and Efficacy of Probiotic LH76 in Modulating Gut Microbiota and Enhancing Intestinal Health in Healthy Adults
This study aims to evaluate the safety and efficacy of the probiotic LH76 as a dietary supplement in healthy adults. The research will assess its effects on gut microbiota composition, intestinal health, and immune function compared to a placebo. Key outcomes include changes in microbial diversity, intestinal barrier integrity, and immune response markers over the intervention period. The findings will contribute to understanding the potential health benefits of LH76 and its role in supporting gut and immune health.
- Conditions
- Gut Microbiota Modulation
- Being tested
- probiotic LH76, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic LH76Dietary supplement
Intervention with LH76 (30 billion CFU/ day, 3g) was administered daily for 8 weeks. Store in a cool, dry place.
PlaceboDietary supplement
Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Probiotic group | Experimental | Not described Receives: Dietary Supplement: probiotic LH76 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gut Microbiota Composition in Response to LH76 Supplementation
This study assesses the impact of LH76 supplementation on gut microbiota diversity and composition using high-throughput sequencing. The primary objective is to determine whether LH76 supplementation leads to significant improvements in gut microbiota balance compared to a placebo. Changes in microbial diversity, relative abundance of beneficial bacteria will be analyzed to assess the probiotic's effectiveness.
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 start11 May 2025 (estimated)
- Primary completion20 May 2025 (estimated)
- Study completion26 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut Microbiota ModulationStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- 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
- 50 participants (estimated)
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
- NCT06875375
- Sponsor's protocol ID
- WK20250309
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Efficacy of Probiotic LH76 in Modulating Gut Microbiota and Enhancing Intestinal Health in Healthy Adults
- ClinicalTrials.gov ID
- NCT06875375
- Acronym / sponsor ID
- WK20250309
- Conditions
- Gut Microbiota Modulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 May 2025 (estimated)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 26 Oct 2025 (estimated)
- 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.
This study aims to evaluate the safety and efficacy of the probiotic LH76 as a dietary supplement in healthy adults. The research will assess its effects on gut microbiota composition, intestinal health, and immune function compared to a placebo. Key outcomes include changes in microbial diversity, intestinal barrier integrity, and immune response markers over the intervention period. The findings will contribute to understanding the potential health benefits of LH76 and its role in supporting gut and immune health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: Placebo |
| Probiotic group | Experimental | Dietary Supplement: probiotic LH76 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Willing to undergo 3 follow-up visits during the intervention period Be willing to provide blood, urine and stool samples 2 times during the intervention period
- Willing to self-administer probiotic or placebo once a day during the intervention period
- Good eyesight, can read and write, can wear glasses
- Have good hearing and be able to hear and understand all instructions during the intervention
Key exclusion criteria (7 listed)
- Digestive diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease)
- Have a serious neurological condition (epilepsy, stroke, severe head trauma, meningitis in the last 10 years, brain surgery, brain tumor, prolonged coma - not including general anaesthesia)
- Have received/are receiving treatment for the following mental disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
- Take medication for depression or low mood Internal organ failure (heart, liver or kidney failure, etc.)
- Have received radiation or chemotherapy in the past
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 |
|---|---|---|
| probiotic LH76Intervention with LH76 (30 billion CFU/ day, 3g) was administered daily for 8 weeks. Store in a cool, dry place. | Dietary supplement | Probiotic group |
| PlaceboEvery day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place. | Dietary supplement | Placebo group |
Primary outcome
Changes in Gut Microbiota Composition in Response to LH76 Supplementation
Time frame: Week 0 and Week 8
This study assesses the impact of LH76 supplementation on gut microbiota diversity and composition using high-throughput sequencing. The primary objective is to determine whether LH76 supplementation leads to significant improvements in gut microbiota balance compared to a placebo. Changes in microbial diversity, relative abundance of beneficial bacteria will be analyzed to assess the probiotic's effectiveness.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic LH76 in people with Gut Microbiota Modulation, run by Wecare Probiotics Co., Ltd..
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 7 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: opening soon, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fei Xu, Dr. (13671979116, xu.fei@haut.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Gut Microbiota Composition in Response to LH76 Supplementation (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?
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 18 Mar 2025.