A Pilot Study on the Activation of NOD2 Receptors in Preterm Infants by Lactobacillus Reuteri DSM17938
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Concentration of NOD2 ligand in fecal samples
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Masking Description
Open Label
Eligibility Criteria
- Ages
- — to 72 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
DSM17938+Routine clinical treatment
Lactobacillus reuteri DSM17938，5 drops per day by mouth (containing at least 100 million CFU of Lactobacillus reuteri DSM17938)
Intervention: DSM17938+Routine clinical treatment (Other)
Routine clinical treatment
Routine clinical treatment
Outcomes
Primary Outcomes
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
- 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))