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A study to compare the effect of single strain and multi-strain probiotics for prevention of an intestinal disease in preterm neonates

Single strain versus multi-strain probiotics for prevention of Necrotizing Enterocolitis in very preterm neonates - A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053480
Enrollment
382
Registered
2023-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P779- Necrotizing enterocolitis in newborn, unspecified

Interventions

Intervention1: Single strain probiotic: Single strain probiotic composed of Bifidobacterium breve M-16V Dose: less than 1 kg weight- half sachet once daily more than 1 kg weight: 1 sachet once daily R

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates less than 32 weeks gestational age

Exclusion criteria

Exclusion criteria: 1. Neonates with gastrointestinal malformations 2. Presence of any contra indications to enteral feeds in the first 7 days of life 3. Neonates already diagnosed with necrotising enterocolitis

Design outcomes

Primary

MeasureTime frame
To compare incidence of NEC stage II and III and late onset sepsis in both groupsTimepoint: Till 33 weeks of corrected gestational age or till discharge—

Secondary

MeasureTime frame
To assess adverse effects to probiotics, all cause mortality, duration of hospital stayTimepoint: Till 33 weeks of corrected gestational age or till discharge—

Countries

India

Contacts

Public ContactAmeena Aboo

Kovai Medical Center and Hospital

arsrinivasar@gmail.com9487217694

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026