InfectionsPhase 3RONiNCT02802059
E. Coli Nissle 1917 - Suspension for Infection Prophylaxis
A Phase 3 study testing EcN-Suspension in people with Infections, run by Ardeypharm GmbH at 6 sites in 2 countries.
Trial summary
This study evaluates the long term effects of E. coli strain Nissle 1917 (EcN-Suspension) probiotic bacteria administration on the number of both, bacterial and viral infections during the first 24 months of infant's life. Read more about this study
- Who is it for?
- Ages Up to 120 hoursHealthy volunteers can take part
- Conditions the study is for
- Infections
- What is being tested?
- EcN-Suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 567 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 7 Oct 2015to 12 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Up to 120 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Signed informed consent form by the parents
- Age at inclusion: max. 120 hours after birth
- Functionally mature infant
- Gestational age more than 35th week of development
- Mother's intention to breastfeed the participant
- Readiness of the mother to administer no probiotics additionally to the trial medication
Who cannot join
- Non-fulfilment of the at least one inclusion criteria
- Lack of propensity/compliance of mother
- 5 min APGAR SCORE less than 5
- 10 min APGAR SCORE less than 8
- pH of umbilical cord blood less than 7 (Determination not obligatory, if APGAR SCORES do not indicate that the child may have suffered from a perinatal asphyxia)
- Any perinatal infection required antibiotic treatment
Show all 10Show fewer
- Birth weight less than 2000 g
- TORCH-infection of the mother
- HIV-infection of the mother
- Any severe medical condition of mother or newborn which in the opinion of the investigator may have a critical impact on the conduct of the study.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany4 sites
Krankenhaus St. Elisabeth & St. Barbara
Halle, 06110
Universitätsklinikum Jena - Klinik für Kinder- und Jugendmedizin
Jena, 07747
Klinikum Westbrandenburg
Potsdam, 14467
Klinikum Südstadt Rostock - Abteilung für Neonatologie
Rostock, 18059
Poland2 sites
Oddział Kliniczny Noworodków, Wcześniaków z Intensywną Terapią Noworodka wraz z Wyjazdowym Zespołem "N"
Bydgoszcz, 85-168
Samodzielny Publiczny Dziecięcy Szpital Kliniczny Oddział Kliniczny Neonatologiiul
Warsaw, 02-091
About this study
This study evaluates the long term effects of E. coli strain Nissle 1917 (EcN-Suspension) probiotic bacteria administration on the number of both, bacterial and viral infections during the first 24 months of infant's life. Half of study participants will receive EcN-Suspension, while the other half will receive placebo. In an additional non-clinical explorative evaluation will furthermore be investigated whether the early intestinal colonization with E.coli strain Nissle 1917 affects the establishment of the intestinal microbiota.
Read the detailed description
In the course of the present trial the participants will be observed during the first 24 months of life, starting right after birth.
All newborns meeting all inclusion criteria and non-fulfilling any exclusion criteria will be included into the trial. Each participant of this clinical trial will be randomly allocated to one of the two trial arms, by using the method of randomly permuted blocks.
The newborns will be primarily treated during the first three weeks of life and re-treated after 6 and 12 months according to trial interventional plan.
Data on the efficacy and safety will be recorded during control visits after first month, 6, 12, 18 and 24 months.
A follow-up examination of study participants will be performed two years after the end of the participation in the present trial (i.e. at an age of 48 months), during which each child will be examined for its normal physical and cognitive development (covered by the U8 standardized examination). In addition data on allergic/atopic complaints or symptoms will be recorded.
In an additional non-clinical explorative evaluation, it will furthermore be investigated whether the early intestinal colonization with E.coli strain Nissle 1917 affects the establishment of the intestinal microbiota. Therefore stool samples of study participants will be collected at an age of 24 and 48 months. The microbial composition of these samples will be characterized and compared between the two trial arms (EcN vs. placebo).
- Conditions
- Infections
- Being tested
- EcN-Suspension, Placebo
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EcN-SuspensionDrug
Also called E. coli strain Nissle 1917 bacteria
Initial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks).
Subsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day).
PlaceboDrug
Initial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks).
Subsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day).
| Study group | Role | What they receive |
|---|---|---|
| EcN-Suspension | Experimental | 279 healthy functionally mature newborn infants up to 35 weeks gestational age, treated with EcN-Suspension Receives: Drug: EcN-Suspension |
| Placebo | Placebo comparator | 279 healthy functionally mature newborn infants up to 35 weeks gestational age, treated with Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infections
The total number of infections observed for each participant during its individual study participation standardised per month during the first 24 months of life.
An infection is an episode of illness caused by:
- Acute upper respiratory tract infections
- Acute lower respiratory tract infections
- Otitis media
- Gastroenteritis
- Urinary tract infections
The duration of an episode of illness is defined as the time from the appearance of the first symptom of a study relevant infection to the disappearance of the last symptom. Infections that occur concurrently or one after another within a period of 7 days are only counted separately, if they belong to different groups of illness.
All rhinitides that occur in the first year of a child's life are considered for the count of the primary efficacy variable. Rhinitides that occur in the second year will only be included if they were accompanied by fever (body temperature higher than 38.4°C during at least one measure).
Measured: during the first 24 months of life
Secondary outcomes (6)
Severity of the course of infections considered as primary variables quantified as the "duration of infections"
duration of infection = the number of days with at least one symptom
Measured: during the first 24 months of infants' life
Severity of the course of infections considered as primary variables quantified as the "number of hospital admissions caused by infections"
number of hospital admissions caused by infections
Measured: during the first 24 months of infants' life
Severity of the course of infections considered as primary variables quantified as the "mean number of in-hospital spent days due to infections"
mean number of in-hospital spent days due to infections
Measured: during the first 24 months of infants' life
Severity of the course of infections considered as primary variables quantified as the "number of antibiotic treatments due to infections".
number of antibiotic treatments due to infections
Measured: during the first 24 months of infants' life
Severity of the course of infections considered as primary variables quantified as the "number of adverse events".
number of adverse events
Measured: during the first 24 months of infants' life
Severity of the course of infections considered as primary variables quantified as the "tolerance to trial medication".
Tolerance of trial medication will be assessed by the investigator and scored "very good", "good", "moderate", or "poor".
Measured: during the first 24 months of infants' life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start7 Oct 2015
- Primary completion12 Oct 2020
- Study completion12 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardeypharm GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc, Clinscience Sp. z o.o.
- Responsible party
- Sponsor
- Investigators
- Corinna Wolff, Dipl-Biophys, Study director, Ardeypharm GmbHDirk M Olbertz, MD, Principal investigator, Klinikum Südstadt Rostock - Abteilung für Neonatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802059
- Sponsor's protocol ID
- MU 1441
- Other IDs
- 2015-001763-39, 2015
- Acronym
- RONi
- Status last verified
- Sep 2020
- First submitted
- 18 Jan 2016
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E. Coli Nissle 1917 - Suspension for Infection Prophylaxis
- ClinicalTrials.gov ID
- NCT02802059
- Acronym / sponsor ID
- RONi / MU 1441
- Conditions
- Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- Ardeypharm GmbHIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc, Clinscience Sp. z o.o.
- Study start
- 7 Oct 2015 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the long term effects of E. coli strain Nissle 1917 (EcN-Suspension) probiotic bacteria administration on the number of both, bacterial and viral infections during the first 24 months of infant's life. Half of study participants will receive EcN-Suspension, while the other half will receive placebo. In an additional non-clinical explorative evaluation will furthermore be investigated whether the early intestinal colonization with E.coli strain Nissle 1917 affects the establishment of the intestinal microbiota.
Detailed description
In the course of the present trial the participants will be observed during the first 24 months of life, starting right after birth.
All newborns meeting all inclusion criteria and non-fulfilling any exclusion criteria will be included into the trial. Each participant of this clinical trial will be randomly allocated to one of the two trial arms, by using the method of randomly permuted blocks.
The newborns will be primarily treated during the first three weeks of life and re-treated after 6 and 12 months according to trial interventional plan.
Data on the efficacy and safety will be recorded during control visits after first month, 6, 12, 18 and 24 months.
A follow-up examination of study participants will be performed two years after the end of the participation in the present trial (i.e. at an age of 48 months), during which each child will be examined for its normal physical and cognitive development (covered by the U8 standardized examination). In addition data on allergic/atopic complaints or symptoms will be recorded.
In an additional non-clinical explorative evaluation, it will furthermore be investigated whether the early intestinal colonization with E.coli strain Nissle 1917 affects the establishment of the intestinal microbiota. Therefore stool samples of study participants will be collected at an age of 24 and 48 months. The microbial composition of these samples will be characterized and compared between the two trial arms (EcN vs. placebo).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EcN-Suspension | Experimental | Drug: EcN-Suspension279 healthy functionally mature newborn infants up to 35 weeks gestational age, treated with EcN-Suspension |
| Placebo | Placebo comparator | Drug: Placebo279 healthy functionally mature newborn infants up to 35 weeks gestational age, treated with Placebo |
Who may qualify
- Ages
- Up to 120 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Signed informed consent form by the parents
- Age at inclusion: max. 120 hours after birth
- Functionally mature infant
- Gestational age more than 35th week of development
- Mother's intention to breastfeed the participant
Key exclusion criteria (10 listed)
- Non-fulfilment of the at least one inclusion criteria
- Lack of propensity/compliance of mother
- 5 min APGAR SCORE less than 5
- 10 min APGAR SCORE less than 8
- pH of umbilical cord blood less than 7 (Determination not obligatory, if APGAR SCORES do not indicate that the child may have suffered from a perinatal asphyxia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EcN-SuspensionAlso: E. coli strain Nissle 1917 bacteriaInitial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks). Subsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day). | Drug | EcN-Suspension |
| PlaceboInitial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks). Subsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day). | Drug | Placebo |
Primary outcome
Number of infections
Time frame: during the first 24 months of life
The total number of infections observed for each participant during its individual study participation standardised per month during the first 24 months of life. An infection is an episode of illness caused by: * Acute upper respiratory tract infections * Acute lower respiratory tract infections * Otitis media * Gastroenteritis * Urinary tract infections The duration of an episode of illness is defined as the time from the appearance of the first symptom of a study relevant infection to the disappearance of the last symptom. Infections that occur concurrently or one after another within a period of 7 days are only counted separately, if they belong to different groups of illness. All rhinitides that occur in the first year of a child's life are considered for the count of the primary efficacy variable. Rhinitides that occur in the second year will only be included if they were accompanied by fever (body temperature higher than 38.4°C during at least one measure).
6 secondary outcomes
Severity of the course of infections considered as primary variables quantified as the "duration of infections"
Time frame: during the first 24 months of infants' life
Severity of the course of infections considered as primary variables quantified as the "number of hospital admissions caused by infections"
Time frame: during the first 24 months of infants' life
Severity of the course of infections considered as primary variables quantified as the "mean number of in-hospital spent days due to infections"
Time frame: during the first 24 months of infants' life
Severity of the course of infections considered as primary variables quantified as the "number of antibiotic treatments due to infections".
Time frame: during the first 24 months of infants' life
Severity of the course of infections considered as primary variables quantified as the "number of adverse events".
Time frame: during the first 24 months of infants' life
Severity of the course of infections considered as primary variables quantified as the "tolerance to trial medication".
Time frame: during the first 24 months of infants' life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Corinna Wolff, Dipl-Biophys study director
Ardeypharm GmbH
Dirk M Olbertz, MD principal investigator
Klinikum Südstadt Rostock - Abteilung für Neonatologie
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EcN-Suspension in people with Infections, run by Ardeypharm GmbH at 6 sites in 2 countries.
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 6 inclusion and 10 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 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Poland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of infections (time frame: during the first 24 months of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2020.