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

November 28, 2025 updated by: Hayatabad Medical Complex
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotic group - Intervention
This group will receive intervention
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
Other Names:
  • Multistrain Probiotic
Placebo Comparator: Placebo
This group will receive 10% DW
Drug: 10% dextrose
This will receive 10% DW as placebo
Other Names:
  • Dextrose water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants who develop NEC on probiotic vs placebo
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hayatabad Medical Complex

Investigators

  • Principal Investigator: Romisa Romisa, MBBS, FCPS, Hyatabad Medical Complex

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Estimated)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERB # 2731
  • Agha Khan (Other Grant/Funding Number: Agha Khan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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