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

NCT07233382 | Not Yet Recruiting

• 2 other identifiers: ERB # 2731Agha Khan
• Study Type: interventional
• Target: 196
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

NEC; NEC - Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (1)

• Number of participants who develop NEC on probiotic vs placebo

  30 days

Study Arms (2)

Probiotic group - Intervention

ACTIVE COMPARATOR

This group will receive intervention

Drug: Probiotic

Placebo

PLACEBO COMPARATOR

This group will receive 10% DW

Drug: 10% dextrose

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

Also known as: Multistrain Probiotic

Probiotic group - Intervention

10% dextrose DRUG

This will receive 10% DW as placebo

Also known as: Dextrose water

Placebo

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Infants with congenital or developmental gastrointestinal disorders for example omphalocele, malrotation, gastroschisis.
• Infants with severe sepsis or gastrointestinal bleeding on presentation

Sponsors & Collaborators

• Hayatabad Medical Complex: lead

Related Publications (1)

• Pammi M, Cope J, Tarr PI, Warner BB, Morrow AL, Mai V, Gregory KE, Kroll JS, McMurtry V, Ferris MJ, Engstrand L, Lilja HE, Hollister EB, Versalovic J, Neu J. Intestinal dysbiosis in preterm infants preceding necrotizing enterocolitis: a systematic review and meta-analysis. Microbiome. 2017 Mar 9;5(1):31. doi: 10.1186/s40168-017-0248-8.

  PMID: 28274256 RESULT

Related Links

• Davis BE, Leppert MO, German K, Lehmann CU, Adams-Chapman I, COUNCIL ON CHILDREN WITH DISABILITIES, et al. Primary care framework to monitor preterm infants for neurodevelopmental outcomes in early childhood.

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Probiotics; Glucose

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Romisa Romisa, MBBS, FCPS

  Hyatabad Medical Complex

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romisa Rehman, MBBS, FCPS

CONTACT

+923219059305; measa_awan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share