To Study the effect of oral probiotics supplementation on illnesses in newborns born premature (before 36 weeks of gestation)

To study the effect of probiotics Supplementation on Morbidities in Indian Preterm Neonates. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/069824

Enrollment

300

Registered

2024-07-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: K553- Necrotizing enterocolitis

Interventions

Intervention1: Probiotic preparation Infloran?: containing probiotics including Lactobacillus Acidophilus 1.0000 billion CFU and Bifidobacterium Bifidum 1.0000 billion CFU in each capsule Study Durati

Eligibility

Inclusion criteria

Inclusion criteria: Gestation Neonates born before less than 34weeks Age at recruitment within 7 days of life Weight low birth weight less than 1800 grams

Exclusion criteria

Exclusion criteria: Malformation of the gut (omphalocele, gastroschisis, intestinal atresia) Neonates with central venous catheter Any condition that prevents oral or nasogastric intake

Design outcomes

Primary

Measure	Time frame
suspected or confirmed positive Bell stage 2 or moreTimepoint: Everyday until the period of hospital stay and further upto 6 weeks of life	—

Secondary

Measure	Time frame
Culture positive sepsis: blood culture positive Clinical sepsis: clinical features of sepsis without positive blood cultureTimepoint: Day 42 after the birth	—

Countries

India

Contacts

Public ContactDr Nehal Athreyi R

RNT Medical College & Hospital, Udaipur

rntianasif@gmail.com9785056044

Outcome results

None listed

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