Intestinal HealthNCT06873425
Research on the Improvement of Intestinal and Immune Functions by Probiotics
A study testing Probiotic in people with Intestinal Health, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
Evaluate the effectiveness and safety of Limosilactobacillus fermentum LF61 as a food supplement compared to a placebo in improving intestinal and immune functions 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
- Intestinal Health
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2025to 30 Dec 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 one of the 7 probiotics (BI45, BBi32, LS97, LB42, LF61, LH76, LR08)/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 -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xu fei
Zhengzhou, Henan, 210095
Fei Xu, 13671979116 ext. +86, xu.fei@haut.edu.cn
About this study
Official title: A Study on the Safety and Effectiveness of Limosilactobacillus Fermentum LF61 in Improving Intestinal and Immune Functions
Evaluate the effectiveness and safety of Limosilactobacillus fermentum LF61 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.
- Conditions
- Intestinal Health
- Being tested
- Probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Dietary supplement: Probiotics. The trial period of this study lasts for 2 months (8 weeks), during which each participant will have 3 visits (at month 0, month 1, and month 2).
PlaceboDietary supplement
Dietary supplement: Placebo. The trial period of this study lasts for 2 months (8 weeks), during which each participant will have 3 visits (at month 0, month 1, and month 2).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | Intervention with Limosilactobacillus fermentum LF61 (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.
Change of concentration of antimicrobial peptide LL-37
Detected by Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: Week 0 and Week 8
Change in calcarein concentration
Detected by Enzyme-Linked Immunosorbent Assay (ELISA).
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 posted12 Mar 2025
- Study start10 Mar 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal HealthStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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
- NCT06873425
- Sponsor's protocol ID
- WK20250303
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 12 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety and Effectiveness of Limosilactobacillus Fermentum LF61 in Improving Intestinal and Immune Functions
- ClinicalTrials.gov ID
- NCT06873425
- Acronym / sponsor ID
- WK20250303
- Conditions
- Intestinal Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 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 effectiveness and safety of Limosilactobacillus fermentum LF61 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Active comparator | Dietary Supplement: ProbioticIntervention with Limosilactobacillus fermentum LF61 (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 (5 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 one of the 7 probiotics (BI45, BBi32, LS97, LB42, LF61, LH76, LR08)/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 (8 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.)
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 |
|---|---|---|
| ProbioticDietary supplement: Probiotics. The trial period of this study lasts for 2 months (8 weeks), during which each participant will have 3 visits (at month 0, month 1, and month 2). | Dietary supplement | Probiotic group |
| PlaceboDietary supplement: Placebo. The trial period of this study lasts for 2 months (8 weeks), during which each participant will have 3 visits (at month 0, month 1, and month 2). | Dietary supplement | Placebo group |
Primary outcome
Change of concentration of antimicrobial peptide LL-37
Time frame: Week 0 and Week 8
Detected by Enzyme-Linked Immunosorbent Assay (ELISA).
Change in calcarein concentration
Time frame: Week 0 and Week 8
Detected by Enzyme-Linked Immunosorbent Assay (ELISA).
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 12 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.
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 Intestinal Health, 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 5 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: opening soon, as of the sponsor's last update on 12 Mar 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?
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 Xu Fei, Doctor (13671979116 ext. +86, 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?
Change of concentration of antimicrobial peptide LL-37 (time frame: Week 0 and Week 8). The study lists 2 primary outcomes in all. 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 12 Mar 2025.