Neonatal InfectionEMSUPNCT01540162
Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement
An observational study of Neonatal Infection, run by Odessa National Medical University at 1 site in Ukraine.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Neonatal Infection
- How many people
- 62 participants
- Where
- 1 siteUkraine
- Study dates
- Mar 2011to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm newborns with gestational age of 35-36 weeks
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Neonatal Infection
- Keywords
- preterm newborn, neonatology, EcN, Nissle, Mutaflor, prophylaxis, infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The Number (Rate) of Patients With Acute Respiratory Infections
ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia
Measured: first 28 days of life
Secondary outcomes (2)
The Number (Rate) of Patients With Acute Respiratory Infections
ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia
Measured: 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
Measured: first 12 month of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startMar 2011
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odessa National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mykola L Aryayev, MD PhD, Odessa National Medical University
- Investigators
- Mykola L Aryayev, Prof MD PhD, Principal investigator, Odessa National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540162
- Sponsor's protocol ID
- NIS MU 1128 AO
- Acronym
- EMSUP
- Status last verified
- Aug 2015
- First submitted
- 16 Feb 2012
- Last updated
- 10 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 29713493
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01540162
- Acronym / sponsor ID
- EMSUP / NIS MU 1128 AO
- Conditions
- Neonatal Infection
- Keywords
- preterm newborn, neonatology, EcN, Nissle, Mutaflor, prophylaxis, infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Odessa National Medical UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Feb 2012 (estimated)
- Results
- Posted 10 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm newborns with gestational age of 35-36 weeks
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
The Number (Rate) of Patients With Acute Respiratory Infections
Time frame: first 6 month of life
The Number (Rate) of Patients With Acute Respiratory Infections
Time frame: first 12 month of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29713493Aryayev 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mykola L Aryayev, Prof MD PhD principal investigator
Odessa National Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Infection, run by Odessa National Medical University at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number (Rate) of Patients With Acute Respiratory Infections (time frame: first 28 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01540162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2015.