Activation of NOD2 Receptors in Preterm Infants by Lactobacillus Reuteri DSM17938

NCT06782061 | Completed DMC

• 1 other identifier: NFEC-2024-654
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To evaluate the capacity of Lactobacillus reuteri DSM17938 to activate NOD2 receptors in preterm infants. Secondary Objective: To analyze the impact of Lactobacillus reuteri DSM17938 on the gut microbiome of preterm infants

Conditions

Preterm Infants

Keywords

DSM17938; NOD2; preterm infant

Outcome Measures

Primary Outcomes (1)

• Concentration of NOD2 ligand in fecal samples

  The supernatants of fecal samples were used to examine the content of NOD2 ligand with the human NOD2/NF-κB/secreted embryonic alkaline phosphatase (SEAP) reporter HEK293 cell

  Pre-intervention Phase: On the 3rd day after birth (V1), 7th day (V2), and 10th day (V3). Intervention Phase: During the intervention period, on the 2nd day (V4), 4th day (V5), 6th day (V6), 8th day (V7), 10th day (V8), 12th day (V9), and 14th day (V10)

Secondary Outcomes (2)

• Relative Abundance of Operational Taxonomic Units (OTUs) in Fecal Samples

  Pre-intervention Phase: On the 3rd day after birth (V1), 7th day (V2), and 10th day (V3). Intervention Phase: During the intervention period, on the 2nd day (V4), 4th day (V5), 6th day (V6), 8th day (V7), 10th day (V8), 12th day (V9), and 14th day (V10)

• Concentration of DSM17938 per Gram of Feces Quantified by qPCR

  Pre-intervention Phase: On the 3rd day after birth (V1), 7th day (V2), and 10th day (V3). Intervention Phase: During the intervention period, on the 2nd day (V4), 4th day (V5), 6th day (V6), 8th day (V7), 10th day (V8), 12th day (V9), and 14th day (V10)

Study Arms (2)

DSM17938+Routine clinical treatment

EXPERIMENTAL

Lactobacillus reuteri DSM17938，5 drops per day by mouth (containing at least 100 million CFU of Lactobacillus reuteri DSM17938)

Other: DSM17938+Routine clinical treatment

Routine clinical treatment

NO INTERVENTION

Routine clinical treatment

Interventions

DSM17938+Routine clinical treatment OTHER

Lactobacillus reuteri DSM17938，5 drops per day by mouth (containing at least 100 million CFU of Lactobacillus reuteri DSM17938)，Routine clinical treatment

DSM17938+Routine clinical treatment

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants with a gestational age of less than 37 weeks.
• Birth weight of less than 2500 grams.
• Hospitalized within 72 hours after birth.
• Parents or legal guardians have signed an informed consent form.

You may not qualify if:

• Congenital digestive tract malformations, genetic metabolic diseases, or congenital immunodeficiency diseases.
• A history of severe asphyxia, infection, or liver and kidney dysfunction at birth/enrollment.
• Death within 72 hours after birth.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Wei Shen, Doctor

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 17, 2025
• Study Start: December 26, 2024
• Primary Completion: January 19, 2025
• Study Completion: January 19, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The study data will be accessible for sharing during a specified temporal window, initiating three months after study completion and publication, with availability extending through a two-year period post-publication.
• Access Criteria: Data can be shared with researchers for scientific purposes upon application to the corresponding author. The research institution's ethics committee and data safety committee will review such requests. Data sharing will be permitted only following committee approval and after proper de-identification of patient information.

Locations

CN (1)