E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Following viral and bacterial infections:
- Acute upper respiratory tract infections (i.e. rhinopharyngitis, laryngitis, angina tonsillitis, tracheitis) - Acute lower respiratory tract infections (i.e. bronchitis, bronchiolitis, bronchopneumonia, pneumonia) - Otitis media - Gastroenteritis - Urinary tract infections.
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E.1.1.1 | Medical condition in easily understood language |
Viral and bacterial infecrions. |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective is to show that the administration of E.coli strain Nissle 1917 results in the reduction of the number of both bacterial and viral infections during the first 24 months of infant’s life. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to show that the administration of E. coli strain Nissle reduces of the severity of the course of the infections considered as primary variables and to reveal that the trial medication is generally well tolerated. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Additional non-clinical explorative evaluation: The aim of the additional evaluation is to investigate whether the early intestinal colonization with E. coli strain Nissle 1917 affects the establishment of the intestinal microbiota. |
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E.3 | Principal inclusion criteria |
- Signed informed consent form by the parents - Age at first intake of trial medication: max. 120 hours after birth - Functionally mature infant - Gestational age more than 35th week of development - Intention of the mother to breast feed the participant - Readiness of the mother to administer no probiotics additionally to the trial medication to the participant during entire course of the study. |
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E.4 | Principal exclusion criteria |
- 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 - 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The number of following infections confirmed by paediatricians’ diagnoses:
- Acute upper respiratory tract infections (i.e. rhinopharyngitis, laryngitis, angina tonsillitis, tracheitis) - Acute lower respiratory tract infections (i.e. bronchitis, bronchiolitis, bronchopneumonia, pneumonia) - Otitis media - Gastroenteritis - Urinary tract infections |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After observation period of 24 months. |
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E.5.2 | Secondary end point(s) |
The reduction of the severity of the course of the infections considered as primary variables: - Duration of the infection (number of days with at least one symptom) - Number of hospital admissions caused by infections - Mean number of in-hospital spent days - Number of antibiotic treatments - Adverse events - Tolerance to trial medication
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After observation period of 24 months. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |