This trial is active, not recruiting.

Condition neonatal infection
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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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.

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by Odessa National Medical University.