Microecological TherapyEarly Phase 1probioticsNCT06716047
Effects of DL-endopeptidase Producing Probiotics on Human Intestinal NOD2 Ligands and Related Functions
A Early Phase 1 study testing Oral administration in people with Microecological Therapy and Probiotic Intervention, run by Zhujiang Hospital at 1 site in China.
Trial summary
We have discovered a type of probiotic that can target activating intestinal NOD2, which is related to a series of human health issues. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Microecological Therapy, Probiotic Intervention
- What is being tested?
- Oral administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2024to 30 Dec 2025
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Tend to participate the trial
- Willing to provide written informed consent
Who cannot join
- Recent use of probiotics, antibiotics, laxatives, or gastrointestinal ulcer medications within the past month.
- Gastrointestinal symptoms (e.g., constipation, abdominal pain, diarrhea, melena, hematochezia) in the past month.
- Other conditions considered by researchers for exclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of DL-endopeptidase Produced by Probiotics on Human Intestinal NOD2 Ligands and Related Functions
We have discovered a type of probiotic that can target activating intestinal NOD2, which is related to a series of human health issues.
Read the detailed description
This trial requires the subjects to take probiotics for a certain period of time, and we will collect blood, stool and questionnaires for subsequent testing, efficacy evaluation and safety evaluation.
- Conditions
- Microecological Therapy, Probiotic Intervention
- Being tested
- Oral administration
- Keywords
- probiotics, safty, microecological therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral administrationOther
Take it directly
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | resistant dextrin Receives: Other: Oral administration |
| probiotics | Experimental | lactobacillus Receives: Other: Oral administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
safty
Adverse reaction by questionnaire survey
Measured: up to 2 weeks
NOD2 activation level
the level of NOD2 activation by fecal in vitro experiments
Measured: up to 2 weeks
Secondary outcomes (1)
Intestinal barrier
Intestinal Barrier markers
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start5 Dec 2024
- Primary completion25 Jun 2025
- 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 Microecological TherapyStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716047
- Sponsor's protocol ID
- ZhujiangHZD
- Acronym
- probiotics
- Status last verified
- Dec 2025
- First submitted
- 14 Oct 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For personal privacy security
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of DL-endopeptidase Produced by Probiotics on Human Intestinal NOD2 Ligands and Related Functions
- ClinicalTrials.gov ID
- NCT06716047
- Acronym / sponsor ID
- probiotics / ZhujiangHZD
- Conditions
- Microecological Therapy, Probiotic Intervention
- Keywords
- probiotics, safty, microecological therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 4 Dec 2024 (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.
We have discovered a type of probiotic that can target activating intestinal NOD2, which is related to a series of human health issues.
Detailed description
This trial requires the subjects to take probiotics for a certain period of time, and we will collect blood, stool and questionnaires for subsequent testing, efficacy evaluation and safety evaluation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: Oral administrationresistant dextrin |
| probiotics | Experimental | Other: Oral administrationlactobacillus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Tend to participate the trial
- Willing to provide written informed consent
Key exclusion criteria (3 listed)
- Recent use of probiotics, antibiotics, laxatives, or gastrointestinal ulcer medications within the past month.
- Gastrointestinal symptoms (e.g., constipation, abdominal pain, diarrhea, melena, hematochezia) in the past month.
- Other conditions considered by researchers for exclusion
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 |
|---|---|---|
| Oral administrationTake it directly | Other | placebo, probiotics |
Primary outcome
safty
Time frame: up to 2 weeks
Adverse reaction by questionnaire survey
NOD2 activation level
Time frame: up to 2 weeks
the level of NOD2 activation by fecal in vitro experiments
1 secondary outcome
Intestinal barrier
Time frame: up to 2 weeks
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 7 Jan 2026.
- Individual participant dataSharing planned: No. For personal privacy security
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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 Early Phase 1 study testing Oral administration in people with Microecological Therapy and Probiotic Intervention, run by Zhujiang Hospital 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 3 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
safty (time frame: up to 2 weeks). 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 7 Jan 2026.