Activation of NOD2 Receptors in Preterm Infants by Lactobacillus Reuteri DSM17938 (NOD2-Pilot)

Nanfang Hospital, Southern Medical University

Status: Completed

Conditions: Preterm Infants

Treatments: Other: DSM17938+Routine clinical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06782061

NFEC-2024-654

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: Under 72 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

DSM17938+Routine clinical treatment

Experimental group

Description:

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

Treatment:

Other: DSM17938+Routine clinical treatment

Routine clinical treatment

No Intervention group

Description:

Routine clinical treatment