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

Sponsor
Hayatabad Medical Complex
Study ID
NCT07233382
Status
Not Yet Recruiting

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Conditions

  • NEC
  • NEC - Necrotizing Enterocolitis

Eligibility Criteria

Sex
ALL
Age
N/A - 1 Day
Healthy Volunteers
Accepted

Interventions

  • Probiotic — DRUG
    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
  • 10% dextrose — DRUG
    This will receive 10% DW as placebo

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Nov 2025
Primary completion
May 30, 2026
Completion
May 30, 2026

Study Design

Enrollment
196 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Probiotic group - Intervention
    This group will receive intervention
  • Placebo Comparator: Placebo
    This group will receive 10% DW

Primary Outcome Measure

Number of participants who develop NEC on probiotic vs placebo [ Time Frame: 30 days ]

Central Contacts

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