NCT01540162

Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Odessa National Medical University · Academic / Other
• Sex: All
• Age: 12 Hours – 24 Hours
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Neonatal Infection

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-07-01
• Completion: 2012-12-01
• First posted: 2012-02-28
• Last updated: 2015-09-10
• Results posted: 2015-09-10

Locations

1 site across 1 country: Ukraine