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Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement

NCT01540162 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2015-09-10

Study results available
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Summary

EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers including those on tube feeding tube, diarrhea in children, prophylactics of pathological colonization in newborns including premature newborns, and improvement of immunity in newborns (mature and premature).

The aim of this trial was to observe efficacy and safety of Mutaflor® SUSPENSION use for immunity improvement in preterm newborn infants

Conditions

  • Neonatal Infection

Sponsors & Collaborators

  • Odessa National Medical University

    lead OTHER

Principal Investigators

  • Mykola L Aryayev, Prof MD PhD · Odessa National Medical University

Eligibility

Min Age
12 Hours
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-07-31
Completion
2012-12-31

Countries

  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01540162 on ClinicalTrials.gov