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Clinical trial to study the effectiveness of pre and probiotic on low birth weight babies

STUDY OF EFFECTIVENESS OF MULTI STRAIN PRE AND PROBIOTIC COMBINATION THERAPY IN LOW BIRTH WEIGHT INFANTS IN A LOW MIDDLE INCOME COUNTRY A DOUBLE BLINDED RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048669
Enrollment
374
Registered
2023-01-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: P369- Bacterial sepsis of newborn, unspecified

Interventions

Intervention1: MULTISTRAIN PRE AND PROBIOTIC COMBINATION THERAPY: ORAL ADMINISTRATION OF MULTI-STRAIN PROBIOTIC CONTAINING L. ACIDOPHILUS, L. RHAMNOSUS, B. LONGUM, S. BOULARDII AND STR. THERMOPHILUS.

Sponsors

SHAILESH CHANDRA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Low birth weight neonates admitted to Neonatal Intensive Care unit fulfilling the following criteria: Weight = 1500 grams and Age of the neonate on recruitment = 7 days Stable clinical condition – “Stable? condition refers to a newborn - without already proven culture positive sepsis, not requiring invasive ventilation or vasopressors for maintaining circulation

Exclusion criteria

Exclusion criteria: Gross congenital malformation  Parent/guardian not providing written consent  Stable neonate in which hospital stay is required for planned  surgical intervention in future

Design outcomes

Primary

MeasureTime frame
Culture proven sepsis within 28 days of randomizationTimepoint: within 28 days of randomization—

Secondary

MeasureTime frame
All cause mortalityTimepoint: Till 28 days or till discharge (whichever applicable);Time to attain full feedsTimepoint: Till discharge;Duration of hospital stayTimepoint: Till discharge;Feed intolerance- periods of gastric residuals and abdominal distension associated with advancing feeding.Timepoint: Till probiotic administration;Neonates developing NECTimepoint: Till discharge—

Countries

India

Contacts

Public ContactDr Sumit Kumar

Rani hospital Ranchi

sumitkumar11100@gmail.com8299631149

Outcome results

None listed

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