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Study the Safety and Efficacy of Probiotics Use in Premature Infants

Study the Safety and Efficacy of Probiotics Use in Premature Infants

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01891604
Enrollment
0
Registered
2013-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2017-05-12

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

Conditions

Infant, Premature, Diseases

Brief summary

Prophylactic enteral probiotics may enhance clinical markers and biomarkers of preterm infants' health, and may also play a role in reducing NEC and associated morbidity.

Interventions

DIETARY_SUPPLEMENTbreast milk with Bifidobacterium Longum subp. Infantis R0033
DIETARY_SUPPLEMENTbreast milk

Sponsors

Lallemand Health Solutions
CollaboratorINDUSTRY
University of Manitoba
Lead SponsorOTHER

Study design

Intervention model
PARALLEL

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Days
Healthy volunteers
Yes

Inclusion criteria

* born with weight\<1500 g * hospitalized within 48 hours after birth

Exclusion criteria

* present with evidence or suspicion of congenital intestinal obstruction * perforation * gastroschisis * large omphalocele * congenital diaphragmatic hernia * major congenital heart defects

Design outcomes

Primary

MeasureTime frame
Calprotectin will be used to determine the effect for probioticsday1 and day30 of the observation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026