Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement (EMSUP)
Recruitment status was Active, not recruiting
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
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540162
|Maternity House №5|
|Odessa, Ukraine, 650000|
|Principal Investigator:||Mykola L Aryayev, Prof MD PhD||Odessa National Medical University|