Effects of DL-endopeptidase Producing Probiotics on Human... | NCT06716047

Studies
Effects of DL-endopeptidase Producing Probiotics on Human Intestinal NOD2 Ligands and Related Functions

NCT06716047

Sponsor

Zhujiang Hospital

Status

Active, not recruiting

Last Update Posted

Jan 7, 2026Actual

Enrollment

30Actual

Phase

Early Phase 1

Conditions

Microecological Therapy
Probiotic Intervention

Interventions

Oral administration

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2024Actual

Primary Completion Date

Jun 25, 2025Actual

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Oct 14, 2024

First Submission Date that Met QC Criteria

Nov 28, 2024

First Posted Date

Dec 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2026

Last Update Posted Date

Jan 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator	resistant dextrin	Other: Oral administration
probiotics	Experimental	lactobacillus	Other: Oral administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral administration	Other	Take it directly	placebo probiotics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
safty	Adverse reaction by questionnaire survey	up to 2 weeks
NOD2 activation level	the level of NOD2 activation by fecal in vitro experiments	up to 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Intestinal barrier	Intestinal Barrier markers	up to 2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Industrial Avenue 253, canton		Guangzhou	Guangzhou	020	China

IPD Sharing Statement Module

Plan to Share IPD

Description

For personal privacy security

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000284	Administration, Oral

Ancestor Terms

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided