Activation of NOD2 Receptors in Preterm Infants by Lactobacillus Reuteri DSM17938

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-26

Study Completion Date

2025-01-19

Brief Summary

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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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Detailed Description

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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.

Conditions

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Preterm Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Open Label

Study Groups

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DSM17938+Routine clinical treatment

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

Group Type EXPERIMENTAL

DSM17938+Routine clinical treatment

Intervention Type OTHER

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

Routine clinical treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DSM17938+Routine clinical treatment

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

Intervention Type OTHER

Eligibility Criteria

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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.

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No