NCT05710575

Role of Probiotic Use in Outcomes of Premature Birth

Completed NA Last updated 11 September 2025

What this trial tests

NA trial testing probiotic in Necrotizing Enterocolitis of Newborn in 100 participants. Completed in 10 September 2023.

Timeline

20 February 2023

Primary endpoint
10 June 2023

10 September 2023

Quick facts

Lead sponsor	University of Health Sciences Lahore
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	100
Start date	20 February 2023
Primary completion	10 June 2023
Estimated completion	10 September 2023
Sites	1 location across Pakistan

Drugs / interventions tested

• probiotic
• placebo

Conditions studied

• Necrotizing Enterocolitis of Newborn — all drugs for Necrotizing Enterocolitis of Newborn →

Sponsor

University of Health Sciences Lahore

Who can join

Adults 28 Weeks to 36 Weeks, any sex, with Necrotizing Enterocolitis of Newborn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Project Summary:

The prevalence of preterm birth ranges from 5% to 18% across 184 countries, and an estimated 15 million infants are born preterm globally. These infants with an immature immune system and gastrointestinal tract are at risk of complications of premature birth, which is the leading cause of neonatal death. According to researcher hypothesis for this study, there is role of probiotics in promoting food tolerance and reducing the incidence and severity of Necrotizing Enterocolitis (NEC) and death related to NEC in pre-term VLBW infants. In the current study, we will examine the effects of probiotics in premature infants and figure out the optimal intervention through randomized controlled trial (RCT).

A prospective, masked, randomized single blinded controlled trial will be conducted in the neonatal intensive care unit (NICU) of Services Hospital Lahore. In this trial the treatment group will receive the probiotics during their first month of life, and the control group will receive no treatment. Primary outcome will be the incidence of death or NEC (≥ stage 2). Death is included as a primary outcome because it is a competing variable of NEC. The x2 test will be used to analyze the categorical data, along with Fisher's exact test when applicable. The Student's t test will be used for continuous data. A logistic regression model will be used to analyze the treatment effects on the primary and secondary outcome variables (death, NEC, and sepsis). Values will be expressed for mean and standard deviation. Statistical significance is set at P-value of 0.05.

The objective of this study is to confirm the evidence and to get the more reliable and authentic results regarding the more effective treatment of NEC in preterm neonates. In this way, the researcher shall be able to improve the outcome of premature births and to reduce the complications by increasing the cure rate. Similarly, it will help the researcher to improve knowledge for better management of NEC in neonates.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.