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Single Vs Multi-strain Probiotics for Preterm Neonates

NCT07296718 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2025-12-22

No results posted yet for this study

Summary

The goal of this randomized control clinical trial is to determine if probiotics can prevent mortality and morbidity in preterm neonates. It also evaluates effects of probiotics on feeding pattern and growth. It will also learn about the comparative effects of single vs multiple strain probiotics.

It aims to answer:

Does probiotics improve the health and growth outcomes in preterm neonates in our population? Does single vs multiple strain of probiotics have difference in effects?

Participants will:

Participants given either single strain or multiple strain probiotics for 28 days post birth.

Data about mortality, morbidity, feeding pattern and growth (weight, height, head circumference gain) recorded on daily basis.

Conditions

  • Necrotizing Enterocolitis of Newborn
  • Sepsis Newborn
  • Growth
  • Feeding Intolerance

Interventions

DIETARY_SUPPLEMENT

Dextrose 10%

P1

DRUG

Lactobacillus Rhamnosus GG

Single Strain

DRUG

Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4

Multiple Strain

Sponsors & Collaborators

  • Madiha, MPhil

    lead OTHER

Principal Investigators

  • Imran Masood, PhD · The Islamia University of Bahawalpur, Khawaja Fareed Campus

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-15
Primary Completion
2023-11-15
Completion
2025-10-15

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07296718 on ClinicalTrials.gov