Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement (EMSUP)
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|ClinicalTrials.gov Identifier: NCT01540162|
Recruitment Status : Completed
First Posted : February 28, 2012
Results First Posted : September 10, 2015
Last Update Posted : September 10, 2015
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
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||62 participants|
|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|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||December 2012|
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.
- The Number (Rate) of Patients With Acute Respiratory Infections [ Time Frame: first 28 days of life ]ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia
- The Number (Rate) of Patients With Acute Respiratory Infections [ Time Frame: first 6 month of life ]ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia
- The Number (Rate) of Patients With Acute Respiratory Infections [ Time Frame: first 12 month of life ]ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540162
|Maternity House №5|
|Odessa, Ukraine, 650000|
|Principal Investigator:||Mykola L Aryayev, Prof MD PhD||Odessa National Medical University|