NCT07233382

Assessing the Efficacy of Probiotics in Prevention of NEC in Preterm Babies

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Hayatabad Medical Complex · Other Government
• Sex: All
• Age: 1 Day
• Healthy volunteers: Accepted

Summary

The goal of the study is to check efficacy of probiotics in preventing necrotizing enterocolitis. The main questions would be if the preterm baby developed NEC or not.

Detailed description

: In the last five years, many systematic reviews have shown the benefit of Probiotics in prevention of NEC and Sepsis in preterm babies but most of these studies have been done in the developed countries. Although the overall benefit has been tilted In favor of use of probiotic however a definitive consensus has not been reached due to inconsistencies in results. Moreover, the impact of multistrain probiotics in our particular population has not been studied, which provides the rationale for our research

Conditions

• NEC
• NEC - Necrotizing Enterocolitis

Interventions

Type	Name	Description
DRUG	Probiotic	All preterm babies \<34 weeks Gestational age admitted within 24 hrs of life will be eligible for the study. Those full filling inclusion criteria and consenting to participate will be recruited. Consent will be obtained by team not caring for the patient. Each recruited patient will be assigned a case ID number. Based on the Randomization babies will be assigned to either the intervention group or control group. Study group: Multistrain probiotic containing a mix of Lactobacillus and Bifidobacterium spp. * Dose is 1 million international units (0.2ml or 5 drops) OD * Started as soon as feed is in initiated
DRUG	10% dextrose	This will receive 10% DW as placebo

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2025-11-18
• Last updated: 2025-12-05