NCT06782061

Activation of NOD2 Receptors in Preterm Infants by Lactobacillus Reuteri DSM17938

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 72 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Infants

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2024-12-26
• Primary completion: 2025-01-19
• Completion: 2025-01-19
• First posted: 2025-01-17
• Last updated: 2025-01-22

Locations

1 site across 1 country: China