Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement

NCT01540162 | Completed Results

• 1 other identifier: NIS MU 1128 AO
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

Neonatal Infection

Keywords

preterm newborn; neonatology; EcN; Nissle; Mutaflor; prophylaxis; infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Number (Rate) of Patients With Acute Respiratory Infections

  first 6 month of life

• The Number (Rate) of Patients With Acute Respiratory Infections

  first 12 month of life

Study Arms (2)

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.

Eligibility Criteria

• Age: 12 Hours - 24 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm newborns with gestational age of 35-36 weeks

You may qualify if:

• age 12-24 hours of life;
• st 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odessa National Medical University: lead

Study Sites (1)

Maternity House №5

Odesa, 650000, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 29713493 DERIVED

MeSH Terms

Conditions

Infections

Results Point of Contact

• Title: Prof. Mykola L. Aryayev, MD & PhD
• Organization: National Medical University Odessa

nataly_kononenko@ukr.net

+380 48 740 5249

Study Officials

• Mykola L Aryayev, Prof MD PhD

  Odessa National Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 28, 2012
• Study Start: March 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 10, 2015
• Results First Posted: September 10, 2015

Record last verified: 2015-08

Locations

UA (1)