- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06716047
Effects of DL-endopeptidase Producing Probiotics on Human Intestinal NOD2 Ligands and Related Functions (probiotics)
January 4, 2026 updated by: Zhujiang Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangzhou
-
Guangzhou, Guangzhou, China, 020
- Industrial Avenue 253, canton
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Tend to participate the trial
- Willing to provide written informed consent
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo
resistant dextrin
|
Take it directly
|
|
Experimental: probiotics
lactobacillus
|
Take it directly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
safty
Time Frame: up to 2 weeks
|
Adverse reaction by questionnaire survey
|
up to 2 weeks
|
|
NOD2 activation level
Time Frame: up to 2 weeks
|
the level of NOD2 activation by fecal in vitro experiments
|
up to 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intestinal barrier
Time Frame: up to 2 weeks
|
Intestinal Barrier markers
|
up to 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 5, 2024
Primary Completion (Actual)
June 25, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
October 14, 2024
First Submitted That Met QC Criteria
November 28, 2024
First Posted (Actual)
December 4, 2024
Study Record Updates
Last Update Posted (Actual)
January 7, 2026
Last Update Submitted That Met QC Criteria
January 4, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZhujiangHZD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
For personal privacy security
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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