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

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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Key information

Conditions

NEC Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases NEC - Necrotizing Enterocolitis

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

: 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Multistrain Probiotic

10% Dextrose

Drug

This will receive 10% DW as placebo

Other names: Dextrose water

Primary outcomes

Number of participants who develop NEC on probiotic vs placebo

Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Romisa Rehman, MBBS, FCPS

CONTACT

[email protected]

+923219059305

Sponsors and collaborators

Lead sponsor

Hayatabad Medical Complex

Other Gov

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Nov 18, 2025
Registry last updated: Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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