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Completed

NCT Number: NCT06782061

Activation of NOD2 Receptors in Preterm Infants by Lactobacillus Reuteri DSM17938

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

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Key information

Conditions

Preterm Infants Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

About this study

This study was designed as an open-label, stratified, randomized, parallel-controlled pilot study, using gestational age as the stratification factor. Participants were stratified according to birth gestational age < 32 weeks, 32 weeks ≤ birth gestational age < 37 weeks, and simple randomization method was used in each gestational age group. All subjects were enrolled after birth/hospital admission, and the experimental group started intervention at 10-14 days after birth, and the intervention period was 14 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Concentration of NOD2 ligand in fecal samples

    Time frame: 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)

    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

Secondary outcomes

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

    Time frame: 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)

    DNA extraction was performed using the QIAamp Mini Kit following the manufacturer's instructions. The V4 hypervariable region of the 16S ribosomal RNA (rRNA) gene was amplified and sequenced on an Illumina ISEQ 100 platform, generating 250 bp paired-end reads. Raw sequencing data quality was assessed and controlled using fastp (v0.23.2). Adapter sequences corresponding to the V3-V4 region were removed with cutadapt. Amplicon sequence variants (ASVs) were identified by denoising the paired-end FASTQ files with DADA2 (v1.6.0) in R. Representative sequences were aligned using the PyNAST algorithm (v1.2.2), and a phylogenetic tree was constructed with FastTree (v2.1.3). Taxonomic classification of ASVs was performed using the Ribosomal Database Project (RDP) classifier against the Greengenes database. To minimize biases from variations in sequencing depth, all samples were rarefied before downstream analyses.

  2. Concentration of DSM17938 per Gram of Feces Quantified by qPCR

    Time frame: 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)

    Quantitative fluorescence PCR (qPCR) was used to detect DSM17938

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

A Pilot Study on the Activation of NOD2 Receptors in Preterm Infants by Lactobacillus Reuteri DSM17938

Acronym: NOD2-Pilot

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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