A study of the Effect of Probiotic organism administration on Feeding Tolerance in Very Low Birth Weight Newborn babies

Effect of Probiotics on Feed Tolerance in Very Low Birth Weight Neonates- A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/08/002853

Enrollment

126

Registered

2012-08-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: -

Interventions

Intervention1: probiotic satchets: Lactobacillus Spp,Bifidobacter Spp,Saccharomyces boulardi oral 1 satchet once a day orally mixed in breast milk till discharge Control Intervention1: breast milk: br

Eligibility

Inclusion criteria

Inclusion criteria: All neonates (infants in the first 28 days of life) with a birth weight less than 1.5kg, admitted to NICU SJMCH Bangalore. Postnatal age <2wks and started enteral feeds.

Exclusion criteria

Exclusion criteria: • Neonates GI tract anomalies, severe congenital malformations. • Refusal of consent. • Not started enteral feeds by day 14 of life. • Outborn babies fed within 72 hrs

Design outcomes

Primary

Measure	Time frame
time to reach full enteral feedsTimepoint: till discharge	—

Secondary

Measure	Time frame
o incidence of feed intolerance o incidence of NEC stage 2 or more o duration of hospital stay o days on TPN o weight gain o mortality Timepoint: till diascharge	—

Countries

India

Contacts

Public ContactDrShashidharA

srekha74@rediffmail.com

Outcome results

None listed

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