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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01540162
First Posted: February 28, 2012
Last Update Posted: September 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mykola L Aryayev, MD PhD, Odessa National Medical University
  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 Mykola L Aryayev, MD PhD, Odessa National Medical University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 62
Study Start Date: March 2011
Study Completion Date: December 2012
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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

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
First Submitted: February 16, 2012
First Posted: February 28, 2012
Results First Submitted: August 12, 2015
Results First Posted: September 10, 2015
Last Update Posted: September 10, 2015
Last Verified: August 2015

Keywords provided by Mykola L Aryayev, MD PhD, Odessa National Medical University:
preterm newborn
neonatology
EcN
Nissle
Mutaflor
prophylaxis
infection