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

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

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

Study Overview

• Status: Completed
• Conditions: Neonatal Infection

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.

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Ukraine
  • Odessa, Ukraine, 650000
    • Maternity House №5

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 hours to 1 day (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Preterm newborns with gestational age of 35-36 weeks

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number (Rate) of Patients With Acute Respiratory Infections	ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia	first 28 days of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number (Rate) of Patients With Acute Respiratory Infections	ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia	first 6 month of life
The Number (Rate) of Patients With Acute Respiratory Infections	ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia	first 12 month of life

Collaborators and Investigators

• Sponsor: Odessa National Medical University
• Investigators: Principal Investigator: Mykola L Aryayev, Prof MD PhD, Odessa National Medical University

Publications and helpful links

General Publications

• Aryayev ML, Senkivska LI, Bredeleva NK, Talashova IV. Prophylaxis of acute respiratory infections via improving the immune system in late preterm newborns with E. coli strain Nissle 1917: a controlled pilot trial. Pilot Feasibility Stud. 2018 Apr 23;4:79. doi: 10.1186/s40814-018-0271-y. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: February 22, 2012
• First Posted (ESTIMATE): February 28, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 10, 2015
• Last Update Submitted That Met QC Criteria: August 12, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: infection; prophylaxis; Mutaflor; neonatology; EcN; preterm newborn; Nissle
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: NIS MU 1128 AO