drugset / Trial / NCT01469273
Prophylaxis of Gastrointestinal Infections With EcN
Phase 4
Unknown
198 enrolled
Hospital San Bartolome
Instituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo y Enfermedades Metabolicas · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This interventional trial shall investigate the efficacy and tolerance of a suspension with non-pathogenic probiotic E. coli strain Nissle (EcN) on prophylaxis against gastrointestinal infections in newborn and infants. ECN-SUSPENSION is a probiotic containing viable E. coli bacteria of the non-pathogenic Nissle 1917 strain at a concentration of 10exp8 cells per ml.
Timeline
- Start
- 2011-11
- Primary completion
- 2013-05
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nissle 1917 | Other / unclassified | 1 ml | — |