Clinical trial NCT06782061: Activation of NOD2 Receptors in Preterm Infants by Lactobacillus Reuteri DSM17938
Official title: A Pilot Study on the Activation of NOD2 Receptors in Preterm Infants by Lactobacillus Reuteri DSM17938
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infants
Keywords: DSM17938
NOD2
preterm infant
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 15
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel
Primary purpose: OTHER

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Concentration of NOD2 ligand in fecal samples
timeFrame: 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:
measure: Relative Abundance of Operational Taxonomic Units (OTUs) in Fecal Samples
timeFrame: 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)
measure: Concentration of DSM17938 per Gram of Feces Quantified by qPCR
timeFrame: 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)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Wei Shen, Doctor
role: STUDY_CHAIR
References: