A clinical trial to study whether probiotics vsl#3 can prevent the occurrence of neonatal sepsis in low birth weight infants during 0-2 months of life.

Effect of Probiotics VSL#3 on prevention of sepsis in LBW infants during 0-2 month period: A Randomized Controlled trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000049

Enrollment

1340

Registered

2008-04-30

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

None listed

Interventions

Intervention1: probiotics VSL#3: 10 billion once daily during the first month of life. Control Intervention1: Placebo:

Eligibility

Inclusion criteria

Inclusion criteria: Eligibility: All live born LBW (>=1500 to ï?£ 2500 gms) babies available in the hospital would be eligible for the study if they have the following inclusion criteria. Inclusion criteria: 1. Birth weight >=1500 gms to ï?£ 2500 gms, 2. Residence within 15-20 Kms of the hospital, 3.The mother is planning to stay in Delhi/ study area for a period of at least two months Exclusion criteria: 1. Extreme prematurity (

Exclusion criteria

Exclusion criteria: Extreme Prematurity 2. Presence of a gross congenital malformation incompatible with life,

Design outcomes

Primary

Measure	Time frame
incidence of clinically suspected sepsis.Timepoint: during 0-2 months of life	—

Secondary

Measure	Time frame
Overall morbidity, gut colonization pattern of probiotic strains, side effects of probiotics supplementation Timepoint: during 0-2 months of life	—

Countries

India

Contacts

Public ContactDr Anju Sinha

apradhandr@gmail.com011-26589493

Outcome results