Single Vs Multi-strain Probiotics for Preterm Neonates

NCT07296718 | Completed Phase 4

• 1 other identifier: NEOPRO-SvsM
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Probiotics; Preterm neonates; Single vs Multiple strain

Outcome Measures

Primary Outcomes (1)

• Necrotizing enterocolitis (NEC)

  Bell's classification used for grading and diagnosis

  From the day intervention started to day 28 of supplementation

Secondary Outcomes (5)

• Neonatal Sepsis

  From the day intervention started to day 28 of supplementation

• Feeding Intolerance

  From the day intervention started to day 28 of supplementation

• Weight

  From the day intervention started to day 28 of supplementation

• Body length

  From the day intervention started to day 28 of supplementation

• Head Circumference

  From the day study started to day 28 of supplementation

Study Arms (3)

P1

PLACEBO COMPARATOR

1 ml of 10% dextrose water will be dispensed in 5cc syringe and administered orally or via feeding tube for 28 days.

Dietary Supplement: Dextrose 10%

P2

ACTIVE COMPARATOR

Single strain probiotic- Lactobacillus rhamnosus GG. The single dose 1.5×109 CFU/day as 1 mL of the reconstituted solution will be given every day via the feeding tube or orally as applicable until reaching feeds of 50 mL/kg/day. It will be increased thereafter to 3×109 CFU/day once feeds exceed 50mL/kg/day.

Drug: Lactobacillus Rhamnosus GG

P3

ACTIVE COMPARATOR

Multiple strain probiotic-Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4. The single dose 1.5×109 CFU/day as 1 mL of the reconstituted solution will be given every day via the feeding tube or orally as applicable until reaching feeds of 50 mL/kg/day. It will be increased thereafter to 3×109 CFU/day once feeds exceed 50mL/kg/day.

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

Interventions

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

Multiple Strain

Also known as: Amybact

P3

Dextrose 10% DIETARY_SUPPLEMENT

P1

Also known as: Placebo

P1

Lactobacillus Rhamnosus GG DRUG

Single Strain

Also known as: Prepro GG

P2

Eligibility Criteria

• Age: Up to 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Madiha, MPhil: lead

Study Sites (1)

Bahawal Victoria Hospital

Bahawalpur, Punjab Province, 62100, Pakistan

Location

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Imran Masood, PhD

  The Islamia University of Bahawalpur, Khawaja Fareed Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-investigator

Model Details: Placebo-controlled randomized clinical trial

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 22, 2025
• Study Start: May 15, 2023
• Primary Completion: November 15, 2023
• Study Completion: October 15, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)