Prophylaxis of Gastrointestinal Infections in Newborn and Infants With a Suspension Containing the Probiotic Escherichia Coli Strain Nissle (PIURA)

NCT01469273 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Hospital San Bartolome
Phase	Phase 4
Status	UNKNOWN
Enrolment	198
Start date	2011-11
Completion	2013-12

Conditions

• Infantile Diarrhea

Interventions

• Mutaflor® Suspension

Primary outcomes

• Number of diarrhea episodes — 12 months / first year of life
  To show superiority of a prophylaxis with a probiotic suspension containing E. coli strain Nissle against gastrointestinal infections associated with diarrhea, compared to an untreated control group

Countries

Peru