Intestinal and Immune Function ImprovedNCT06873438
The Effect of Probiotics on the Improvement of Intestinal and Immune Function
A study testing Probiotic group in people with Intestinal and Immune Function Improved, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
Evaluate the effectiveness and safety of Lactobacillus delbrueckii subsp. bulgaricus LB42 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 and Immune Function Improved
- What is being tested?
- Probiotic group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 15 Aug 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
- Age 18-45 years
- Willing to undergo 3 follow-up visits during the intervention period
- Willing to provide 2 blood, urine, and stool samples during the intervention period
- Willing to self-administer one of the probiotics/placebo once daily during the intervention period
- Good eyesight, able to read and write, and can wear glasses
- Have good hearing and be able to hear and understand all instructions during the intervention
Who cannot join
- Suffering from digestive disorders, mainly gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease)
- Has a severe neurological condition (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, prolonged coma - excluding general anesthesia)
- Has received/is receiving treatment for the following psychiatric disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
- Take medication for depression or low mood
- Suffering from internal organ failure (heart, liver, or kidney failure, etc.)
- Radiotherapy or chemotherapy in the past
- Surgery/procedure under general anesthesia within the past three years, or planned to undergo a procedure/procedure under general anesthesia within the next 3 months during this trial
- Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Safety and Effectiveness of Lactobacillus Delbrueckii Subsp. Bulgaricus LB42 in Improving Intestinal and Immune Functions
Evaluate the effectiveness and safety of Lactobacillus delbrueckii subsp. bulgaricus LB42 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.
- Conditions
- Intestinal and Immune Function Improved
- Being tested
- Probiotic group, Placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic groupDietary supplement
The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).
Placebo groupDietary supplement
The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Lactobacillus delbrueckii subsp. bulgaricus LB42 (30 billion CFU/day, 3g) was administered daily for 8 weeks. Store in a cool and dry place. Receives: Dietary Supplement: Probiotic group |
| Placebo group | Placebo comparator | Every day to give 3g dextrin intervention for 8 weeks. Store in a cool and dry place. Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the concentration of LL-37 in feces before and after intervention.
Detected by Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: Week 0 and Week 8
Secondary outcomes (2)
Change in the composition of fecal microbiota before and after intervention.
Analyzed by 16s RNA sequencing.
Measured: Week 0 and Week 8
Change in the concentration of calprotectin in feces before and after intervention.
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 start1 Mar 2025
- Primary completion25 May 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal and Immune Function ImprovedStudies 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
- 52 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
- NCT06873438
- Sponsor's protocol ID
- WK20250304
- Status last verified
- Sep 2025
- First submitted
- 3 Mar 2025
- Last updated
- 3 Oct 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 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety and Effectiveness of Lactobacillus Delbrueckii Subsp. Bulgaricus LB42 in Improving Intestinal and Immune Functions
- ClinicalTrials.gov ID
- NCT06873438
- Acronym / sponsor ID
- WK20250304
- Conditions
- Intestinal and Immune Function Improved
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- 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 Lactobacillus delbrueckii subsp. bulgaricus LB42 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
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probiotic groupLactobacillus delbrueckii subsp. bulgaricus LB42 (30 billion CFU/day, 3g) was administered daily for 8 weeks. Store in a cool and dry place. |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupEvery day to give 3g dextrin intervention for 8 weeks. Store in a cool and dry place. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-45 years
- Willing to undergo 3 follow-up visits during the intervention period
- Willing to provide 2 blood, urine, and stool samples during the intervention period
- Willing to self-administer one of the probiotics/placebo once daily during the intervention period
- Good eyesight, able to read and write, and can wear glasses
Key exclusion criteria (8 listed)
- Suffering from digestive disorders, mainly gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease)
- Has a severe neurological condition (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, prolonged coma - excluding general anesthesia)
- Has received/is receiving treatment for the following psychiatric disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
- Take medication for depression or low mood
- Suffering from 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 |
|---|---|---|
| Probiotic groupThe experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8). | Dietary supplement | Probiotic group |
| Placebo groupThe experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8). | Dietary supplement | Placebo group |
Primary outcome
Change in the concentration of LL-37 in feces before and after intervention.
Time frame: Week 0 and Week 8
Detected by Enzyme-Linked Immunosorbent Assay (ELISA).
2 secondary outcomes
Change in the composition of fecal microbiota before and after intervention.
Time frame: Week 0 and Week 8
Change in the concentration of calprotectin in feces before and after intervention.
Time frame: Week 0 and Week 8
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 3 Oct 2025.
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 group in people with Intestinal and Immune Function Improved, 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 6 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 3 Oct 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?
Change in the concentration of LL-37 in feces before and after intervention. (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 3 Oct 2025.