NCT06716047

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Dec 2024

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

December 5, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

October 14, 2024

Last Update Submit

January 4, 2026

Conditions

Probiotic InterventionMicroecological Therapy

Keywords

probioticssaftymicroecological therapy

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Intestinal barrier

    up to 2 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

resistant dextrin

Other: Oral administration

probiotics

EXPERIMENTAL

lactobacillus

Other: Oral administration

Interventions

Oral administrationOTHER

Take it directly

placeboprobiotics

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Tend to participate the trial
  • Willing to provide written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Industrial Avenue 253, canton

Guangzhou, Guangzhou, 020, China

Location

MeSH Terms

Interventions

Administration, Oral

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2024

First Posted

December 4, 2024

Study Start

December 5, 2024

Primary Completion

June 25, 2025

Study Completion

December 30, 2025

Last Updated

January 7, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

For personal privacy security

Locations

CN(1)