Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement
This trial is active, not recruiting.
|Sponsor||Odessa National Medical University|
|Start date||March 2011|
|End date||July 2012|
|Trial size||62 participants|
|Trial identifier||NCT01540162, NIS MU 1128 AO|
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
Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
Patients of group II remain unexposed to the probiotic Mutaflor.
Male or female participants up to 24 hours old.
Inclusion Criteria: - age 12-24 hours of life; - 1st degree of prematurity (functionally mature infant, gestational age 35-36 weeks); - exclusive breast feeding during study; - both parents must sign and date an informed consent for infant's participation in the study. Exclusion Criteria: - perinatal asphyxia ( Apgar score less than 8); - significant concomitant disease (congenital birth defects, perinatal encephalopathy, TORCH - infections and other infectious disease of newborn, respiratory distress syndrome ets); - clinically significant changes in blood analyze results (if needed); - use of other probiotics or prebiotics during the first 28 days of study participation.
|Official title||Open-labelled, Controlled, Parallel Group Study to Assess the Efficacy and Safety of MUTAFLOR in 3 Weeks Treatment for Immunity Improvement in Preterm Infants With 1 Year Follow-up Period|
|Principal investigator||Mykola L Aryayev, Prof MD PhD|
|Description||Study design: open-labeled, controlled, parallel group, non-interventional 3-weeks-study with followed prospective observation during 1 week and 1 year follow-up period. Patients of group I take the probiotic Mutaflor orally in the dose 1 ml once a day during first week of life and three times per week during the second and third week of life. Patients of the group II don't take specific probiotic for immunity strengthening.|
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