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

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-05-30

Brief Summary

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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.

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Detailed Description

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: 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

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NEC NEC - Necrotizing Enterocolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Probiotic group - Intervention

This group will receive intervention

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type 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

Placebo

This group will receive 10% DW

Group Type PLACEBO_COMPARATOR

10% dextrose

Intervention Type DRUG

This will receive 10% DW as placebo

Interventions

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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

Intervention Type DRUG

10% dextrose

This will receive 10% DW as placebo

Intervention Type DRUG

Other Intervention Names

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Multistrain Probiotic Dextrose water

Eligibility Criteria

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Inclusion Criteria

* Male and female preterm infants with a gestational age less than 35 weeks.
* All indoor patients and outdoor patients who present within 24hrs of birth

Exclusion Criteria

* • Infants with congenital or developmental gastrointestinal disorders for example omphalocele, malrotation, gastroschisis.

* Infants with severe sepsis or gastrointestinal bleeding on presentation

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes