NCT04541771

The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants

The Role of Lactobacillus Reuteri (L. Reuteri) in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Less Than 34 Weeks of Gestation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Children's Hospital and Institute of Child Health, Multan · Other Government
• Sex: All
• Age: 28 Weeks – 34 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the effectiveness of L. Reuteri with placebo in prevention of NEC in children, as according to my knowledge, there is limited work is done nationally and internationally. Probiotics are being used in our Children Hospital and the Institute of Child Health, Multan. Route of administration of L. Reuteri will be oral or via nasogastric tube due to availability of oral form in Pakistan. The results of this study will be helpful to assess the beneficial effects of probiotics especially L. Reuteri in NEC in preterm. So, they can be recommended as preventive strategy to avoid NEC development and its complications based on its availability, effectivity and easy administration

Conditions

• Necrotizing Enterocolitis
• Sepsis

Interventions

Type	Name	Description
DRUG	Lactobacillus Reuteri DSM 17938	The trial group will receive their usual feeds plus daily probiotic addition 1 drop/kg/dose twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds
DRUG	Placebo	expressed breast milk/formula milk plus normal saline drop from the beginning of enteral feedings till the baby attain full feeds

Timeline

• Start date: 2020-10-01
• Primary completion: 2020-12-01
• Completion: 2021-01-01
• First posted: 2020-09-09
• Last updated: 2020-09-09