Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-02-21 @ 2:54 PM
Study NCT ID:
NCT07296718
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2025-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Vs Multi-strain Probiotics for Preterm Neonates
Sponsor:
Madiha, MPhil
Organization:
Study Overview
Official Title:
Evaluation of the Clinical and Growth-related Effects of Probiotics in Preterm Infants: A Randomized, Placebo Controlled Clinical Trial.
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: