Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement (EMSUP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Odessa National Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Mykola L. Aryayev, MD, PhD, Odessa National Medical University
ClinicalTrials.gov Identifier:
NCT01540162
First received: February 16, 2012
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

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
Neonatal Infection

Study Type: Observational
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

Further study details as provided by Odessa National Medical University:

Enrollment: 62
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)
Groups/Cohorts
Group I
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.
Group II
Patients of group II remain unexposed to the probiotic Mutaflor.

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.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Preterm newborns with gestational age of 35-36 weeks

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01540162

Locations
Ukraine
Maternity House №5
Odessa, Ukraine, 650000
Sponsors and Collaborators
Odessa National Medical University
Investigators
Principal Investigator: Mykola L Aryayev, Prof MD PhD Odessa National Medical University
  More Information

No publications provided

Responsible Party: Mykola L. Aryayev, MD, PhD, Professor, MD, PhD, Odessa National Medical University
ClinicalTrials.gov Identifier: NCT01540162     History of Changes
Other Study ID Numbers: NIS MU 1128 AO
Study First Received: February 16, 2012
Last Updated: February 22, 2012
Health Authority: Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Odessa National Medical University:
preterm newborn
neonatology
EcN
Nissle
Mutaflor
prophylaxis
infection

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on October 23, 2014