Clinical trial NCT01540162: Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Infection
Keywords: preterm newborn
neonatology
EcN
Nissle
Mutaflor
prophylaxis
infection
Lead sponsor: Odessa National Medical University
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 62
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm newborns with gestational age of 35-36 weeks

Brief 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.

Eligibility 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.

Primary outcomes:
measure: The Number (Rate) of Patients With Acute Respiratory Infections
timeFrame: first 28 days of life
Secondary outcomes:
measure: The Number (Rate) of Patients With Acute Respiratory Infections
timeFrame: first 6 month of life
measure: The Number (Rate) of Patients With Acute Respiratory Infections
timeFrame: first 12 month of life
Other outcomes:
Locations:
city: Odessa
country: Ukraine
facility: Maternity House №5
Study officials:
affiliation: Odessa National Medical University
name: Mykola L Aryayev, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.