Skip to main content
OpenTrials
Completed

NCT Number: NCT01540162

Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 hour–24 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Maternity House №5

Odesa, 650000, Ukraine

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Odessa National Medical University

Other

Registry information

Official study 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

Acronym: EMSUP

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 28, 2012
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.