The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants

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Brief Title

The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants

Official Title

The Role of Lactobacillus Reuteri (L. Reuteri) in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Less Than 34 Weeks of Gestation

Brief Summary

      The purpose of this study is to compare the effectiveness of L. Reuteri with placebo in
      prevention of NEC in children, as according to my knowledge, there is limited work is done
      nationally and internationally. Probiotics are being used in our Children Hospital and the
      Institute of Child Health, Multan.

      Route of administration of L. Reuteri will be oral or via nasogastric tube due to
      availability of oral form in Pakistan. The results of this study will be helpful to assess
      the beneficial effects of probiotics especially L. Reuteri in NEC in preterm. So, they can be
      recommended as preventive strategy to avoid NEC development and its complications based on
      its availability, effectivity and easy administration

Study Phase

Phase 2

Study Type


Primary Outcome

narcotizing enterocolitis

Secondary Outcome



Necrotizing Enterocolitis


Lactobacillus Reuteri DSM 17938

Study Arms / Comparison Groups

 drug group
Description:  The trial group will receive their usual feeds plus daily probiotic (Lactobacillus Reuteri DSM 17938) addition 1 drop/kg/dose(. minimum of 20 million live Lactobacillus Reuteri are present in One drop) twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

October 2020

Completion Date

January 2021

Primary Completion Date

December 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Preterm neonate< 34 weeks and >28 weeks of gestation of both genders Hemodynamically

        Exclusion Criteria:

          -  Preterm neonates >34 weeks gestational age < 28 weeks of gestation Cardiorespiratory
             illness Parental refusal




28 Weeks - 34 Weeks

Accepts Healthy Volunteers

Accepts Healthy Volunteers


summera tabasum, 03417236837, [email protected]

Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

The Children Complex & The Institute of Child Health, Multan

Study Sponsor

summera tabasum, Principal Investigator, CH&ICH

Verification Date

September 2020