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Completed

NCT Number: NCT07296718

Single Vs Multi-strain Probiotics for Preterm Neonates

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.

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Key information

Conditions

Necrotizing Enterocolitis of Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Feeding Intolerance Growth Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Sepsis Newborn Systemic Inflammatory Response Syndrome

Age range

Up to 36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bahawal Victoria Hospital

Bahawalpur, Punjab Province, 62100, Pakistan

About this study

This trial is single-centered, parallel, multi-arm, 1:1:1 randomized, blinded, placebo controlled clinical trial. It compares 3 groups; Group P1 (Placebo), Group P2-Single Strain probiotic (Lactobacillus rhamnosus GG) and Group P3- Multiple strains probiotic ( Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4) for preventing preterm neonatal morbidities, improving feeding tolerance and overall growth.

Primary objective: The primary objective of our trial will be to compare the incidence and severity of Necrotizing enterocolitis (NEC) from the time of trial participation till the end of trial treatment (28 days) according to Bell's grading criteria.

Secondary objectives:

All these outcomes will be measured from the day intervention started to the end of supplementation (28 days)

  • To evaluate incidence of sepsis, intracerebral haemorrhage and periventricular leukomalacia, retinopathy of prematurity and bronchopulmonary dysplasia)
  • To estimate the time to full enteral feeding (i.e., ≥150 ml/kg/day) and feeding tolerance based on Davy's Neonatal Feeding Assessment Scale (NFAS).
  • To determine the effect of probiotics on growth (weight, height, and head circumference) of premature babies
  • To assess comparative efficacy of single strain vs combination probiotics for aforementioned objectives

Framework/hypothesis: The experimental group P2 (Lactobacillus rhamnosus GG) and Group P3- ( Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4) are superior to control group (Placebo) as preventing NEC and other morbidities in preterm neonates, thus improving feeding tolerance and overall growth.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Preterm babies of gestational age <35+6days, birth weight <2500 grams, received and tolerated at-least one feed within 72 hours of birth and informed consent from parents or guardian.

Exclusion criteria

  • Neonates with major congenital malformations, gastrointestinal anomalies, early onset sepsis (C-reactive protein (CRP) >10 mg/L in the first 72 h of life) and renal insufficiency

Treatment and study plan

Dextrose 10%

Dietary Supplement

P1

Other names: Placebo

Lactobacillus Rhamnosus GG

Drug

Single Strain

Other names: Prepro GG

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

Drug

Multiple Strain

Other names: Amybact

Primary outcomes

  1. Necrotizing enterocolitis (NEC)

    Time frame: From the day intervention started to day 28 of supplementation

    Bell's classification used for grading and diagnosis

Secondary outcomes

  1. Neonatal Sepsis

    Time frame: From the day intervention started to day 28 of supplementation

    Clinical sepsis is defined as condition with at least two signs of systemic inflammatory response (e.g. temperature >38 C or <36.5 C, tachycardia > 200/min etc.), one laboratory sign (e.g. C-reactive protein >20mg/L) but no proof of causative agent in blood culture. Clinical sepsis with proof of blood culture positive for causative agent was defined as confirmed sepsis.

  2. Feeding Intolerance

    Time frame: From the day intervention started to day 28 of supplementation

    A gastrointestinal tolerance score, based on gastric residual volume, emesis, abdominal distension, number of stools and nil per oral days was calculated to identify and score feeding intolerance. Each score as 1. A score of >2 was considered gastric intolerance.

  3. Weight

    Time frame: From the day intervention started to day 28 of supplementation

    Weight measured in grams

  4. Body length

    Time frame: From the day intervention started to day 28 of supplementation

    Measured in millimeters daily once

  5. Head Circumference

    Time frame: From the day study started to day 28 of supplementation

    Measured in millimeters

Sponsors and collaborators

Lead sponsor

Madiha, MPhil

Other

Registry information

Official study title

Evaluation of the Clinical and Growth-related Effects of Probiotics in Preterm Infants: A Randomized, Placebo Controlled Clinical Trial.

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Dec 22, 2025
Registry last updated
Dec 22, 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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