Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02802059 | E. Coli Nissle 1917 - Suspension for Infection Prophylaxis | PHASE3 | COMPLETED | 567 | — | — | Oct 7, 2015 | Oct 12, 2020 | Oct 27, 2020 | 6 | Germany, Poland |
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).
| Arm | Type | Description |
|---|---|---|
| EcN-Suspension | EXPERIMENTAL | 279 healthy functionally mature newborn infants up to 35 weeks gestational age, treated with EcN-Suspension |
| Placebo | PLACEBO_COMPARATOR | 279 healthy functionally mature newborn infants up to 35 weeks gestational age, treated with Placebo |
| Name | Type | Description |
|---|---|---|
| EcN-Suspension | DRUG | 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). |
| Placebo | DRUG | 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). |
Inclusion Criteria: * 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...